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Report Narrative

Description of Event or Problem

This was a newborn with a large diaphragmatic hernia, who was placed on extracorporal membrane oxygenation - ecmo-. Immediately after ecmo was begun, she developed diffuse petechial lesions which progressed to purpura and hypertension, then dic. She continued to deteriorate and died from hemorrhage secondary to dic. Heparin coated carmeda tubing was used during ecmo and this report is being filed retrospectively after the heparin recall and the 04/08/08 fda letter to manufacturers asking them to consider withdrawal of heparin coated devices. Diagnosis or reason for use: oxygenation.

Narrative Key: 788225

General Information About The Event

Date of event: 2008-01-20

Date initial reporter provided information: 2008-04-14

Number of devices in report:

Number of patients in report:

Suspected adverse outcome in a patient: N

Report is about the quality, performance, or safety of a device: Y

Source

Report source: Voluntary report

Is reporter a health professional: Y

Initial reporter occupation: Risk Manager

Submitted copy of report to FDA: No answer provided

Single-use device that was reprocessed and reused?: N

Manufacturer Information

Name:

Country:

Location:

Contact Person:

Contact Person County:

Contact Address: ,

Contact Phone Number:

Contact Extention:

Device # 1 - Carmeda circuit - heparin coated, Carmeda circuit - heparin coated

Device Event Key: 970812

FDA Product Code Classification: DTZ

Model Number: *

Catalog Number: *

Lot Number: 8664127

Expiration Date of Device:

Age of Device:

Device Operator: Health Professional

Implanted?: N

Date Implanted Device Removed: B

Evaluation By Manufacturer

Device Available For Evaluation: No

Date Returned to Manufacturer:

Device Evaluated By Manufacturer:

Remedial Action Taken At Time of Report: [""]

Removal Reporting Number:

Report Narrative

Additional Manufacturer Narrative

This is an initial report. An investigation is in process. A final report will be submitted when the investigation is completed.

Narrative Key: 8094441

Additional Manufacturer Narrative

(b)(4). Concomitant medical products: cell-dyn sapphire hemoglobin syringe, list # 8h49-02 this follow up mdr for remedial correction 2919069-8/6/07-004-c is submitted late. The cell-dyn sapphire hemoglobin syringe, list number 8h49-02, was manufactured on (b)(4) 2007 and was identified by the vendor to have been manufactured with insufficient or inconsistent amount of silicone lubricant applied to the tip of the syringe plunger. The affected syringes with a package date of (b)(4) 2007 through (b)(4) 2007, caused the cell-dyn sapphire analyzer to generate an error message upon installation of the syringe or shortly thereafter. The cell-dyn sapphire hemoglobin syringe was distributed for the cell-dyn sapphire analyzer only and did not impact other cell-dyn analyzers. The issue was resolved when a new cell-dyn sapphire hemoglobin syringe, list 8h49-04, was manufactured by a new vendor and released for distribution on (b)(4) 2009.

Narrative Key: 8303917

Description of Event or Problem

The customer contacted abbott regarding hemoglobin syringe "fail to home" error messages generated five times in one day from the cell-dyn sapphire hematology analyzer. The customer was able to clear the error message with temporary resolution. The abbott customer technical advocate recommended the customer clean the syringe and if the syringe plunger was difficult to move, replace the syringe. The issue was resolved when the customer replaced the syringe. The customer reported there was no impact to pt management.

Narrative Key: 788224

General Information About The Event

Date of event: 2007-12-16

Date initial reporter provided information: 2008-01-22

Number of devices in report:

Number of patients in report:

Suspected adverse outcome in a patient: N

Report is about the quality, performance, or safety of a device: Y

Source

Report source: Manufacturer report

Is reporter a health professional: N

Initial reporter occupation: Other

Submitted copy of report to FDA: Unknown

Single-use device that was reprocessed and reused?: N

Manufacturer Information

Name:

Country:

Location:

Contact Person: US NOEMI KONDOS RN, BSN

Contact Person County:

Contact Address: ABBOTT PARK IL, 60064

Contact Phone Number: 8479375120

Contact Extention:

Device # 1 - Cell-dyn sapphire analyzer, Automated hematology analyzer

Device Event Key:

FDA Product Code Classification: GKZ

Model Number: NA

Catalog Number: 8H00-01

Lot Number: NA

Expiration Date of Device:

Age of Device: DA

Device Operator: Other

Implanted?:

Date Implanted Device Removed:

Evaluation By Manufacturer

Device Available For Evaluation: Yes

Date Returned to Manufacturer:

Device Evaluated By Manufacturer: Y

Remedial Action Taken At Time of Report: ["Replace"]

Removal Reporting Number: 2919069-8/6/07-004-C

Report Narrative

Additional Manufacturer Narrative

(b)(4). Concomitant medical products: cell-dyn sapphire hemoglobin syringe, list # 8h49-02 this follow up mdr for remedial correction 2919069-8/6/07-004-c is submitted late. The cell-dyn sapphire hemoglobin syringe, list number 8h49-02, was manufactured on (b)(4) 2007 and was identified by the vendor to have been manufactured with insufficient or inconsistent amount of silicone lubricant applied to the tip of the syringe plunger. The affected syringes with a package date of (b)(4) 2007 through (b)(4) 2007, caused the cell-dyn sapphire analyzer to generate an error message upon installation of the syringe or shortly thereafter. The cell-dyn sapphire hemoglobin syringe was distributed for the cell-dyn sapphire analyzer only and did not impact other cell-dyn analyzers. The issue was resolved when a new cell-dyn sapphire hemoglobin syringe, list 8h49-04, was manufactured by a new vendor and released for distribution on (b)(4) 2009.

Narrative Key: 8321587

Description of Event or Problem

The customer contacted abbott regarding hemoglobin syringe "fail to home" error messages generated from the cell-dyn sapphire hematology analyzer. The customer states the hemoglobin syringe locked up and the plunger would not move when the syringe was removed for weekly cleaning. The customer replaced the syringe and no further error messages were generated. The customer requested replacement syringes and reported there was no further issues. The customer reported there was no impact to pt management.

Narrative Key: 15604222

Additional Manufacturer Narrative

This is an initial report. An investigation is in process. A final report will be submitted when the investigation is completed.

Narrative Key: 15887480

General Information About The Event

Date of event: 2007-12-14

Date initial reporter provided information: 2008-01-22

Number of devices in report:

Number of patients in report:

Suspected adverse outcome in a patient: N

Report is about the quality, performance, or safety of a device: Y

Source

Report source: Manufacturer report

Is reporter a health professional: N

Initial reporter occupation: Other

Submitted copy of report to FDA: Unknown

Single-use device that was reprocessed and reused?: N

Manufacturer Information

Name:

Country:

Location:

Contact Person: US NOEMI KONDOS RN, BSN

Contact Person County:

Contact Address: ABBOTT PARK IL, 60064

Contact Phone Number: 8479375120

Contact Extention:

Device # 1 - Cell-dyn sapphire analyzer, Automated hematology analyzer

Device Event Key:

FDA Product Code Classification: GKZ

Model Number: NA

Catalog Number: 8H00-01

Lot Number: NA

Expiration Date of Device:

Age of Device: DA

Device Operator: Other

Implanted?:

Date Implanted Device Removed:

Evaluation By Manufacturer

Device Available For Evaluation: Yes

Date Returned to Manufacturer:

Device Evaluated By Manufacturer: Y

Remedial Action Taken At Time of Report: ["Recall"]

Removal Reporting Number: 2919069-8/6/07-004-C

Report Narrative

Additional Manufacturer Narrative

This is an initial report. An investigation is in process. A final report will be submitted when the investigation is complete.

Narrative Key: 7934126

Description of Event or Problem

Form 3500 must be submitted if a secondary malignant finding occurred. In 2008, mammogram and core biopsy revealed microcalcifications of the left breast - original diagnosis on right side - and a stereotactic core showed dcis.

Narrative Key: 1255386

Additional Manufacturer Narrative

(b)(4). Cell-dyn sapphire hemoglobin syringe, list # 8h49-02 this follow up mdr for remedial correction 2919069-8/6/07-004-c is submitted late. The cell-dyn sapphire hemoglobin syringe, list number 8h49-02, was manufactured on (b)(6) 2007 and was identified by the vendor to have been manufactured with insufficient or inconsistent amount of silicone lubricant applied to the tip of the syringe plunger. The affected syringes with a package date of (b)(6) 2007, caused the cell-dyn sapphire analyzer to generate an error message upon installation of the syringe or shortly thereafter. The cell-dyn sapphire hemoglobin syringe was distributed for the cell-dyn sapphire analyzer only and did not impact other cell-dyn analyzers. The issue was resolved when a new cell-dyn sapphire hemoglobin syringe, list 8h49-04, was manufactured by a new vendor and released for distribution on (b)(6) 2009.

Narrative Key: 8322422

Description of Event or Problem

The customer contacted abbott regarding intermittent hemoglobin syringe "fail to home" error messages generated from the cell-dyn sapphire hematology analyzer. The customer states the syringe was cleaned and reseated, but error recurred within an hour of syringe cleaning. The customer was instructed to power down the analyzer, but following re-boot of the analyzer, the analyzer primed, and the syringe error recurred during quality control sampling. The abbott customer technical advocate dispatched service to the customer facility. Prior to service arriving at the customer facility, the customer installed a new syringe and the issue was resolved. The customer reported there was no impact to pt management.

Narrative Key: 788210

General Information About The Event

Date of event: 2007-12-10

Date initial reporter provided information: 2008-01-22

Number of devices in report:

Number of patients in report:

Suspected adverse outcome in a patient: N

Report is about the quality, performance, or safety of a device: Y

Source

Report source: Manufacturer report

Is reporter a health professional: N

Initial reporter occupation: Other

Submitted copy of report to FDA: Unknown

Single-use device that was reprocessed and reused?: N

Manufacturer Information

Name:

Country:

Location:

Contact Person: US NOEMI KONDOS RN, BSN

Contact Person County:

Contact Address: ABBOTT PARK IL, 60064

Contact Phone Number: 8479375120

Contact Extention:

Device # 1 - Cell-dyn sapphire analyzer, Automated hematology analyzer

Device Event Key:

FDA Product Code Classification: GKZ

Model Number: NA

Catalog Number: 8H00-01

Lot Number: NA

Expiration Date of Device:

Age of Device: DA

Device Operator: Other

Implanted?:

Date Implanted Device Removed:

Evaluation By Manufacturer

Device Available For Evaluation: Yes

Date Returned to Manufacturer:

Device Evaluated By Manufacturer: Y

Remedial Action Taken At Time of Report: ["Relabeling"]

Removal Reporting Number: 2919069-8/6/07-004-C

Report Narrative

Additional Manufacturer Narrative

(b)(4). Concomitant medical products: cell-dyn sapphire hemoglobin syringe, list # 8h49-02 this follow up mdr for remedial correction 2919069-8/6/07-004-c is submitted late. The cell-dyn sapphire hemoglobin syringe, list number 8h49-02, was manufactured on (b)(4) 2007 and was identified by the vendor to have been manufactured with insufficient or inconsistent amount of silicone lubricant applied to the tip of the syringe plunger. The affected syringes with a package date of (b)(4) 2007 through (b)(4) 2007, caused the cell-dyn sapphire analyzer to generate an error message upon installation of the syringe or shortly thereafter. The cell-dyn sapphire hemoglobin syringe was distributed for the cell-dyn sapphire analyzer only and did not impact other cell-dyn analyzers. The issue was resolved when a new cell-dyn sapphire hemoglobin syringe, list 8h49-04, was manufactured by a new vendor and released for distribution on (b)(4) 2009.

Narrative Key: 8322005

Description of Event or Problem

The customer contacted abbott regarding frequent hemoglobin syringe "fail to home" error messages occuring throughout the day from the cell-dyn sapphire hematology analyzer. The customer had not performed any troubleshooting procedures and the customer was instructed to clean and reseat the syringe. The issue persisted and the customer requested service for the analyzer. The abbott field service rep replaced the syringe, assayed samples without recurrence of error messages and verified the assay controls were within specs. The customer reported there was no impact to pt mgmt.

Narrative Key: 788211

Additional Manufacturer Narrative

This is an initial report. An investigation is in process. A final report will be submitted when the investigation is completed.

Narrative Key: 8094442

General Information About The Event

Date of event: 2007-12-08

Date initial reporter provided information: 2008-01-22

Number of devices in report:

Number of patients in report:

Suspected adverse outcome in a patient: N

Report is about the quality, performance, or safety of a device: Y

Source

Report source: Manufacturer report

Is reporter a health professional: Y

Initial reporter occupation: Medical Technologist

Submitted copy of report to FDA: Unknown

Single-use device that was reprocessed and reused?: N

Manufacturer Information

Name:

Country:

Location:

Contact Person: US NOEMI KONDOS RN, BSN

Contact Person County:

Contact Address: ABBOTT PARK IL, 60064

Contact Phone Number: 8479375120

Contact Extention:

Device # 1 - Cell-dyn sapphire analyzer, Automated hematology analyzer

Device Event Key:

FDA Product Code Classification: GKZ

Model Number: NA

Catalog Number: 8H00-01

Lot Number: NA

Expiration Date of Device:

Age of Device: DA

Device Operator: Other

Implanted?:

Date Implanted Device Removed:

Evaluation By Manufacturer

Device Available For Evaluation: Yes

Date Returned to Manufacturer:

Device Evaluated By Manufacturer: Y

Remedial Action Taken At Time of Report: ["Recall"]

Removal Reporting Number: 2919069-8/6/07-004-C

Report Narrative

Description of Event or Problem

The customer contacted abbot regarding hemaglobin syringe "fail to home" error messages generated from the cell-dyn sapphire hematology analyzer. When the customer removed the syringe to clean it, the syringe plunger was stuck very tightly in the syringe barrel requiring enough force to remove it, that the plunger came all the way out. The customer replaced the syringe which resolved the issue. The customer reported there was no impact to pt management.

Narrative Key: 788226

Additional Manufacturer Narrative

(b)(4). Concomitant medical products: cell-dyn sapphire hemoglobin syringe, list # 8h49-02 this follow up mdr for remedial correction 2919069-8/6/07-004-c is submitted late. The cell-dyn sapphire hemoglobin syringe, list number 8h49-02, was manufactured on (b)(4) 2007 and was identified by the vendor to have been manufactured with insufficient or inconsistent amount of silicone lubricant applied to the tip of the syringe plunger. The affected syringes with a package date of (b)(4) 2007 through (b)(4) 2007, caused the cell-dyn sapphire analyzer to generate an error message upon installation of the syringe or shortly thereafter. The cell-dyn sapphire hemoglobin syringe was distributed for the cell-dyn sapphire analyzer only and did not impact other cell-dyn analyzers. The issue was resolved when a new cell-dyn sapphire hemoglobin syringe, list 8h49-04, was manufactured by a new vendor and released for distribution on (b)(4) 2009.

Narrative Key: 8322004

Additional Manufacturer Narrative

This is an initial report. An investigation is in process. A final report will be submitted when the investigation is completed.

Narrative Key: 7934127

General Information About The Event

Date of event: 2007-12-05

Date initial reporter provided information: 2008-01-22

Number of devices in report:

Number of patients in report:

Suspected adverse outcome in a patient: N

Report is about the quality, performance, or safety of a device: Y

Source

Report source: Manufacturer report

Is reporter a health professional: N

Initial reporter occupation: Other

Submitted copy of report to FDA: Unknown

Single-use device that was reprocessed and reused?: N

Manufacturer Information

Name:

Country:

Location:

Contact Person: US NOEMI KONDOS RN, BSN

Contact Person County:

Contact Address: ABBOTT PARK IL, 60064

Contact Phone Number: 8479375120

Contact Extention:

Device # 1 - Cell-dyn sapphire analyzer, Automated hematology analyzer

Device Event Key:

FDA Product Code Classification: GKZ

Model Number: NA

Catalog Number: 8H00-01

Lot Number: NA

Expiration Date of Device:

Age of Device: DA

Device Operator: Other

Implanted?:

Date Implanted Device Removed:

Evaluation By Manufacturer

Device Available For Evaluation: Yes

Date Returned to Manufacturer:

Device Evaluated By Manufacturer: Y

Remedial Action Taken At Time of Report: ["Replace"]

Removal Reporting Number: 2919069-8/6/07-004-C

Report Narrative

Additional Manufacturer Narrative

A ge service rep performed an on site investigation. Ordered and delivered a replacement image intensifier (ii) power supply to customer. It is believed that this component will address the reported issue. No additional info at this time. If additional info is received that indicates, otherwise an additional report will be filed as required.

Narrative Key: 15565627

Description of Event or Problem

It was reported that the image intensifier (ii) power supply on the 7700 system failed. Request made for a new ii power supply. There was no report of pt injury.

Narrative Key: 15214484

General Information About The Event

Date of event: 2008-02-11

Date initial reporter provided information: 2008-02-19

Number of devices in report:

Number of patients in report:

Suspected adverse outcome in a patient: N

Report is about the quality, performance, or safety of a device: Y

Source

Report source: Manufacturer report

Is reporter a health professional: Y

Initial reporter occupation: Other

Submitted copy of report to FDA: Unknown

Single-use device that was reprocessed and reused?: N

Manufacturer Information

Name:

Country:

Location:

Contact Person: US MARIA FRAME, VP QA/RA

Contact Person County:

Contact Address: SALT LAKE CITY UT, 84116

Contact Phone Number: 8015176440

Contact Extention:

Device # 1 - 7700, Fluoroscopic x-ray

Device Event Key: 996718

FDA Product Code Classification: JAA

Model Number: 7700

Catalog Number: NA

Lot Number: NA

Expiration Date of Device:

Age of Device: DA

Device Operator: Health Professional

Implanted?: N

Date Implanted Device Removed: B

Evaluation By Manufacturer

Device Available For Evaluation: No

Date Returned to Manufacturer:

Device Evaluated By Manufacturer: Y

Remedial Action Taken At Time of Report: [""]

Removal Reporting Number:

Report Narrative

Description of Event or Problem

Have irregular heart rhythms - had pacer replaced due to low battery, still having symptoms which date back to 2000. I recently had pacemaker replaced, due to low battery, and irregular heart rhythms by dr. He mentioned the pacer led to the heart could be fractured or cracked and was concerned, but looked like ok condition when procedure was done. I saw on tv commerical, their commercial medtronic pacer leads being recalled and was concerned because i've had irregular heart beats that's un-explainable, off and on dating back to 2001 when i had my pacer re-programable.

Narrative Key: 18221888

General Information About The Event

Date of event: 2007-09-19

Date initial reporter provided information: 2007-12-16

Number of devices in report:

Number of patients in report:

Suspected adverse outcome in a patient: Y

Report is about the quality, performance, or safety of a device: Y

Source

Report source: Voluntary report

Is reporter a health professional: N

Initial reporter occupation: Patient

Submitted copy of report to FDA: No answer provided

Single-use device that was reprocessed and reused?: N

Manufacturer Information

Name:

Country:

Location:

Contact Person:

Contact Person County:

Contact Address: ,

Contact Phone Number:

Contact Extention:

Device # 1 - Medtronic, Sensia s.r. pacemaker

Device Event Key: 970769

FDA Product Code Classification: DTB

Model Number:

Catalog Number:

Lot Number:

Expiration Date of Device:

Age of Device:

Device Operator: 0

Implanted?: N

Date Implanted Device Removed: B

Evaluation By Manufacturer

Device Available For Evaluation: No

Date Returned to Manufacturer:

Device Evaluated By Manufacturer:

Remedial Action Taken At Time of Report: [""]

Removal Reporting Number:

Report Narrative

Description of Event or Problem

Intractable pain following right inguinal hernia repair with extra large marlex patch and a bard perfix plug. Debilitating right groin pain along the inguinal ligament up toward the anterior superior iliac spine. Pain radiates from the anterior superior iliac spine into the scar and toward the scrotum. There is tenderness in the testicle with pain in the medial thigh skin, the skin around the scrotum, and along the course of the inguinal ligament. There was significant bruising and swelling of the right groin, upper thigh, and scrotum immediately following surgery. Pain mgmt with lidocane patches and trigger point injections failed to be effective. Nerve block produced immediate, but temporary relief. Dates of use: 2005 - 2008. Diagnosis or reason for use: right inguinal hernia.

Narrative Key: 20618755

General Information About The Event

Date of event: 2005-06-30

Date initial reporter provided information: 2008-02-12

Number of devices in report:

Number of patients in report:

Suspected adverse outcome in a patient: Y

Report is about the quality, performance, or safety of a device: N

Source

Report source: Voluntary report

Is reporter a health professional: N

Initial reporter occupation: Patient

Submitted copy of report to FDA: No answer provided

Single-use device that was reprocessed and reused?: N

Manufacturer Information

Name:

Country:

Location:

Contact Person:

Contact Person County:

Contact Address: ,

Contact Phone Number:

Contact Extention:

Device # 1.0 - Marlex patch with bard perfix plug, Bard perfix plug

Device Event Key:

FDA Product Code Classification: FTL

Model Number: *

Catalog Number: *

Lot Number: *

Expiration Date of Device:

Age of Device:

Device Operator: Health Professional

Implanted?:

Date Implanted Device Removed:

Evaluation By Manufacturer

Device Available For Evaluation:

Date Returned to Manufacturer:

Device Evaluated By Manufacturer:

Remedial Action Taken At Time of Report: [""]

Removal Reporting Number:

Report Narrative

Description of Event or Problem

While on a trip, i began having lower back problems while in our car. When we got to the city and met up with family, we began a walking tour. My back was really bothering me, so i began using thermacare for back wrap. I have used it before but not usually when it is so hot outside. I put in on around 10 am, and then went walking. I put it on over my undergarments and under a pair of cotton capri pants. By time 5:00 came, the wrap was twisted and soaking wet and my back was burning. I took off the wrap. When we got back to the hotel, i had my husband look at my back; i had 5 round burn marks across the lower mid-back. I did of course use the thermacare again. When i got home a few days later, i went to my family doctor for the pain and because the burns were not healing. He said 2 of the burns were 2nd degree, and 3 were 1st degree. He used a cleaning solution then put a cream on the burns. He wrote me a prescription for the burns which i used for a couple of weeks. I still have a couple of scars after all these months. I regret i did not make my complaint when this happened. I hope this complaint now will provoke some kind of statement, so that others do not have this event. Dates of use: 2007. Diagnosis or reason for use: lower back pain.

Narrative Key: 16108002

General Information About The Event

Date of event: 2007-08-14

Date initial reporter provided information: 2008-02-12

Number of devices in report:

Number of patients in report:

Suspected adverse outcome in a patient: Y

Report is about the quality, performance, or safety of a device: N

Source

Report source: Voluntary report

Is reporter a health professional: N

Initial reporter occupation: Patient

Submitted copy of report to FDA: No answer provided

Single-use device that was reprocessed and reused?: N

Manufacturer Information

Name:

Country:

Location:

Contact Person:

Contact Person County:

Contact Address: ,

Contact Phone Number:

Contact Extention:

Device # 1 - Thermacare back and hip, Heatwraps

Device Event Key: 969661

FDA Product Code Classification: IMD

Model Number:

Catalog Number:

Lot Number:

Expiration Date of Device:

Age of Device:

Device Operator: 0

Implanted?: N

Date Implanted Device Removed: B

Evaluation By Manufacturer

Device Available For Evaluation: No

Date Returned to Manufacturer:

Device Evaluated By Manufacturer:

Remedial Action Taken At Time of Report: [""]

Removal Reporting Number:

Report Narrative

Description of Event or Problem

Procedure: ivc filter placement. The slip-cath beacon tip catheter inadvertently passed through the internal jugular into the right subclavian artery. Pt had a high inr which increased the pt's potential for bleeding upon removal of the slip-cath beacon tip catheter. Therefore, for the safety of the pt, the pt was taken to the or for removal of the slip-cath beacon tip catheter and suturing of the subclavian artery. Dates of use: 2008. Diagnosis or reason for use: placement of ivc filter.

Narrative Key: 788212

General Information About The Event

Date of event: 2008-01-28

Date initial reporter provided information: 2008-02-12

Number of devices in report:

Number of patients in report:

Suspected adverse outcome in a patient: Y

Report is about the quality, performance, or safety of a device: N

Source

Report source: Voluntary report

Is reporter a health professional: Y

Initial reporter occupation: Risk Manager

Submitted copy of report to FDA: No answer provided

Single-use device that was reprocessed and reused?: N

Manufacturer Information

Name:

Country:

Location:

Contact Person:

Contact Person County:

Contact Address: ,

Contact Phone Number:

Contact Extention:

Device # 1 - Slip-cath beacon tip catheter, Slip-cath

Device Event Key: 969684

FDA Product Code Classification: DQO

Model Number: G11993

Catalog Number: *

Lot Number: G11993

Expiration Date of Device: 20110131

Age of Device:

Device Operator: Health Professional

Implanted?: N

Date Implanted Device Removed: B

Evaluation By Manufacturer

Device Available For Evaluation: No

Date Returned to Manufacturer:

Device Evaluated By Manufacturer:

Remedial Action Taken At Time of Report: [""]

Removal Reporting Number:

Report Narrative

Description of Event or Problem

Pt states ulti-med 0. 5ml low dose insulin syringe is defective. Pt states the increments on the syringe closest to the needle are incorrect because the first line is very close to the needle. He sometimes uses low doses of insulin - 3 or 4 units - and feels that the measurements are not correct because the increment for the first unit is smaller than the other increments. Dose or amount: 1 syringe, four times a day, sq. Diagnosis or reason for use: diabetes rquiring insulin.

Narrative Key: 21634380

General Information About The Event

Date of event: 2008-02-06

Date initial reporter provided information: 2008-02-12

Number of devices in report:

Number of patients in report:

Suspected adverse outcome in a patient: N

Report is about the quality, performance, or safety of a device: Y

Source

Report source: Voluntary report

Is reporter a health professional: Y

Initial reporter occupation: Pharmacist

Submitted copy of report to FDA: No answer provided

Single-use device that was reprocessed and reused?: N

Manufacturer Information

Name:

Country:

Location:

Contact Person:

Contact Person County:

Contact Address: ,

Contact Phone Number:

Contact Extention:

Device # 1 - Ultimed, Insulin syringe

Device Event Key: 969672

FDA Product Code Classification: FMF

Model Number:

Catalog Number:

Lot Number:

Expiration Date of Device:

Age of Device:

Device Operator: 0

Implanted?: N

Date Implanted Device Removed: B

Evaluation By Manufacturer

Device Available For Evaluation: No

Date Returned to Manufacturer:

Device Evaluated By Manufacturer:

Remedial Action Taken At Time of Report: [""]

Removal Reporting Number:

Report Narrative

Description of Event or Problem

Two nurse aides were transferring a resident from shower chair to bed. They lifted him completely out of the chair, removed the chair and the lift arm immediately "gave way" and the resident fell approximately 36" to 40" onto the floor.

Narrative Key: 788227

General Information About The Event

Date of event: 2008-02-08

Date initial reporter provided information: 2008-02-12

Number of devices in report:

Number of patients in report:

Suspected adverse outcome in a patient: Y

Report is about the quality, performance, or safety of a device: N

Source

Report source: Voluntary report

Is reporter a health professional: Y

Initial reporter occupation: Other Health Care Professional

Submitted copy of report to FDA: No answer provided

Single-use device that was reprocessed and reused?: N

Manufacturer Information

Name:

Country:

Location:

Contact Person:

Contact Person County:

Contact Address: ,

Contact Phone Number:

Contact Extention:

Device # 1 - Liko, Uno lift

Device Event Key: 970798

FDA Product Code Classification: FSA

Model Number: 102

Catalog Number:

Lot Number:

Expiration Date of Device:

Age of Device:

Device Operator: Health Professional

Implanted?: N

Date Implanted Device Removed: B

Evaluation By Manufacturer

Device Available For Evaluation:

Date Returned to Manufacturer:

Device Evaluated By Manufacturer:

Remedial Action Taken At Time of Report: [""]

Removal Reporting Number:

Report Narrative

Description of Event or Problem

The intent of this form is to have product code 0010201 and lot number 43 emd237 included in the mandatory recall of bard composix kugel mesh. Following is an explanation of the history for this request. Described first is how i learned of the recall. While visiting my mother in 2007, i viewed a television advertisement. The ad was seeking participants in a class action law suit against the manufacturers of the fda recalled surgical mesh. Since i had suffered four (4) incision hernia surgeries between 2002 and 2004, in which surgical mesh was replaced, i called the toll-free number. I was informed at the time that bard composix kugel mesh patch was subject to mandatory fda recall due to many failures. After receiving my medical records from my surgeons, i discovered that the very same mesh was implanted during the second surgery and removed during the third surgery. I am currently unaware of the mfr of the surgical mesh implanted during the other (3) surgeries. I enrolled as a plaintiff in the class action law suit and am represented. Subsequently, i reread the specifics of the fda mandatory recall of the bard composix kugel mesh patch, and the amended recalls to include additional product codes and lot numbers. Nowhere, to the best of my knowledge, does the product code and lot number implanted in my second surgery appear in the mandatory fda recalls. I will now present a brief history of my surgeries and the adverse effect of the implantation of the bard composix kugel mesh patch. The first hernia surgery, 2001 did not take, it burst through, and the second hernia surgery in 2002 had to be done with kugel patch. Dr. Diagnosed both hernia's and did both surgeries. The third surgery was done in 2003 by another dr. For an infected and recurrent incisional hernia. The incison was 1/2 red and 1/2 normal with the 1/2 red always much warmer then the other normal half and with the red 1/2 having little bumps, like marbles, popping up in the incision. Dr(second) ordered an mri of my incision and determined from the mri the bard composix kugel mesh patch needed to be explanted. A fourth surgery was done on the following month by dr(second) to remove mesh and repair a hernia. Apparently the muscles to which the mesh was being attached, were too weak to hold, because of the previous surgeries. As for adverse effects, not specifically caused by the bard composix kugel mesh patch, but some resulting from surgery, i offer the following: infection, fever, frontal lobe aneurysm requiring embolization and follow-up, stroke, exacerbation of hypothyroidism after any surgery, requiring medication, surgeries shocked my body and threw off all medications, collapsed lung during one surgery due to pain medication and anesthesia, weight gains due to hypothyroidism, blood pressure due to weight gain, on and on an on. Dose or amount: unsure of exact size, not sure if product or device. D&e comlpleted. ; frequency: once. Route: 033. Dates of use: 2002 - 2003. Diagnosis or reason for use: recurrent abdominal incisional hernia. Event abated after use stopped or dose reduced? no.

Narrative Key: 16171889

General Information About The Event

Date of event: 2002-08-27

Date initial reporter provided information: 2008-02-12

Number of devices in report:

Number of patients in report:

Suspected adverse outcome in a patient: Y

Report is about the quality, performance, or safety of a device: Y

Source

Report source: Voluntary report

Is reporter a health professional: N

Initial reporter occupation: Patient

Submitted copy of report to FDA: No answer provided

Single-use device that was reprocessed and reused?: N

Manufacturer Information

Name:

Country:

Location:

Contact Person:

Contact Person County:

Contact Address: ,

Contact Phone Number:

Contact Extention:

Device # 1 - Bard composix kugel mesh patch, Kugel patch

Device Event Key: 971424

FDA Product Code Classification: FTL

Model Number: 0010201

Catalog Number: UNK

Lot Number: 43 EMD237

Expiration Date of Device:

Age of Device:

Device Operator: Health Professional

Implanted?: N

Date Implanted Device Removed: V

Evaluation By Manufacturer

Device Available For Evaluation: No

Date Returned to Manufacturer:

Device Evaluated By Manufacturer:

Remedial Action Taken At Time of Report: [""]

Removal Reporting Number:

Report Narrative

Additional Manufacturer Narrative

Improvements to increase the robustness of the hydraulic connections have been designed and validated and are currently being introduced in the field to avoid the occurrence of tubing disconnection.

Narrative Key: 19342696

General Information About The Event

Date of event:

Date initial reporter provided information:

Number of devices in report:

Number of patients in report:

Suspected adverse outcome in a patient: N

Report is about the quality, performance, or safety of a device: *

Source

Report source: Manufacturer report

Is reporter a health professional: *

Initial reporter occupation: Invalid Data

Submitted copy of report to FDA: No answer provided

Single-use device that was reprocessed and reused?: N

Manufacturer Information

Name:

Country:

Location:

Contact Person: IT FRANCESCO BARDELLI

Contact Person County:

Contact Address: MEDOLLA (MO) , I-410

Contact Phone Number: 53550111

Contact Extention:

Device # 1 - *, *

Device Event Key: 968505

FDA Product Code Classification: KDI

Model Number: *

Catalog Number: *

Lot Number: *

Expiration Date of Device:

Age of Device:

Device Operator: Invalid Data

Implanted?: N

Date Implanted Device Removed: *

Evaluation By Manufacturer

Device Available For Evaluation: No answer provided

Date Returned to Manufacturer:

Device Evaluated By Manufacturer: Y

Remedial Action Taken At Time of Report: [""]

Removal Reporting Number:

Report Narrative

Description of Event or Problem

This pt was the first case of the day and the anesthesia machine had been checked according to the standard checkout procedure recommended by the american society of anesthesiologists. The peak inspiratory pressures read by the machine (ohmeda) spirometer on the ventilator and the extra adaptable spirometer added to the circuit were reading 14-16 & 40 cm h20 respectively. Upon inspection of the inspiratory limb of the circuit co discovered only a pinpoint opening in the blue plastic connector instead of the usual quarter size opening. The circuit was changed and the pt had no adverse outcome. There was significant airflow obstruction with inspiration which could have caused morbidity. Note: hole enlarged after the above event.

Narrative Key: 21392769

General Information About The Event

Date of event: 1997-04-28

Date initial reporter provided information: 1997-04-29

Number of devices in report:

Number of patients in report:

Suspected adverse outcome in a patient: N

Report is about the quality, performance, or safety of a device: Y

Source

Report source: User Facility report

Is reporter a health professional: Y

Initial reporter occupation: Physician

Submitted copy of report to FDA: No

Single-use device that was reprocessed and reused?:

Manufacturer Information

Name:

Country:

Location:

Contact Person:

Contact Person County:

Contact Address: ,

Contact Phone Number:

Contact Extention:

Device # 1 - Vital signs, Adult circle breathing circuit 40 11/101cm

Device Event Key: 98520

FDA Product Code Classification: CAI

Model Number: *

Catalog Number: *

Lot Number: 0444

Expiration Date of Device:

Age of Device: NA

Device Operator: Health Professional

Implanted?: N

Date Implanted Device Removed: *

Evaluation By Manufacturer

Device Available For Evaluation: Device was returned to manufacturer

Date Returned to Manufacturer: 19970509

Device Evaluated By Manufacturer:

Remedial Action Taken At Time of Report: [""]

Removal Reporting Number:

Report Narrative

Description of Event or Problem

When catheter was removed from the artery, after the third pass, the balloon and spring tip were missing. Unable to retrieve. There were no pt complications or injury.

Narrative Key: 15033740

General Information About The Event

Date of event: 1997-03-20

Date initial reporter provided information: 1997-06-02

Number of devices in report:

Number of patients in report:

Suspected adverse outcome in a patient: N

Report is about the quality, performance, or safety of a device: Y

Source

Report source: Manufacturer report

Is reporter a health professional: *

Initial reporter occupation: Other

Submitted copy of report to FDA: No answer provided

Single-use device that was reprocessed and reused?:

Manufacturer Information

Name:

Country:

Location:

Contact Person:

Contact Person County:

Contact Address: ,

Contact Phone Number:

Contact Extention:

Device # 1 - Fogarty arterial embolectomy catheter, Embolectomy catheter

Device Event Key: 98521

FDA Product Code Classification: DXE

Model Number: 12-080-3F

Catalog Number: NA

Lot Number: UNK

Expiration Date of Device:

Age of Device: UNKNOWN

Device Operator: Health Professional

Implanted?: N

Date Implanted Device Removed: *

Evaluation By Manufacturer

Device Available For Evaluation: Device was returned to manufacturer

Date Returned to Manufacturer: 19970416

Device Evaluated By Manufacturer: Y

Remedial Action Taken At Time of Report: [""]

Removal Reporting Number:

Report Narrative

Description of Event or Problem

One or more cracks in grey plastic surrounding filter material. Water flows through these cracks, fills the chamber and causes the heater to heat improperly. Invalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. Invalid data - regarding multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Invalid data - regarding whether event presents imminent hazard. Invalid data - whether device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.

Narrative Key: 5377

General Information About The Event

Date of event:

Date initial reporter provided information: 1994-07-28

Number of devices in report:

Number of patients in report:

Suspected adverse outcome in a patient: *

Report is about the quality, performance, or safety of a device: *

Source

Report source: User Facility report

Is reporter a health professional:

Initial reporter occupation:

Submitted copy of report to FDA:

Single-use device that was reprocessed and reused?:

Manufacturer Information

Name:

Country:

Location:

Contact Person:

Contact Person County:

Contact Address: ,

Contact Phone Number:

Contact Extention:

Device # 1 - Transfer chamber,

Device Event Key: 9652

FDA Product Code Classification:

Model Number:

Catalog Number: 9000

Lot Number: 8382 (SUSPECT MORE THAN 1 LOT#

Expiration Date of Device:

Age of Device:

Device Operator: Invalid Data

Implanted?: *

Date Implanted Device Removed:

Evaluation By Manufacturer

Device Available For Evaluation: No answer provided

Date Returned to Manufacturer:

Device Evaluated By Manufacturer:

Remedial Action Taken At Time of Report: [""]

Removal Reporting Number:

Report Narrative

Description of Event or Problem

Patient started on hemodialysis alarms intact. Machine alarmed, tested for blood in dialysate positive. Hemodialysis stopped no blood returned to patient per hcp. Ebl 250cc per hcpdevice labeled for single use. Patient medical status prior to event: invalid data. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. The device was destroyed/disposed of.

Narrative Key: 614

General Information About The Event

Date of event: 1992-06-29

Date initial reporter provided information: 1992-07-08

Number of devices in report:

Number of patients in report:

Suspected adverse outcome in a patient: Y

Report is about the quality, performance, or safety of a device: N

Source

Report source: Distributor report

Is reporter a health professional: U

Initial reporter occupation: Unknown

Submitted copy of report to FDA: Unknown

Single-use device that was reprocessed and reused?:

Manufacturer Information

Name:

Country:

Location:

Contact Person:

Contact Person County:

Contact Address: ,

Contact Phone Number:

Contact Extention:

Device # 1 - Same as above, Dialyzer

Device Event Key: 956

FDA Product Code Classification: KDI

Model Number: N/A

Catalog Number: 01-2114

Lot Number: 2-0515-11

Expiration Date of Device:

Age of Device:

Device Operator: Other

Implanted?: N

Date Implanted Device Removed:

Evaluation By Manufacturer

Device Available For Evaluation: No

Date Returned to Manufacturer:

Device Evaluated By Manufacturer:

Remedial Action Taken At Time of Report: [""]

Removal Reporting Number:

Report Narrative

Description of Event or Problem

Resident was in bed with both siderails in "up" position. Nursing assistant heard a noise and went into resident's room. Resident was lying on the floor with left arm stuck between the matress frame and siderail; resident was sent to hospital and received treatment for broken arm. Siderail was evaluated in "up" position - siderail lock is in working orderdevice labeled for single use. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, performance tests performed, visual examination. Results of evaluation: storage/shipment, none or unknown, other. Conclusion: no failure detected and product within specification. Certainty of device as cause of or contributor to event: yes. Corrective actions: device use continued with restrictions/limitations, invalid data. Invalid data - on device destroyed/disposed of status.

Narrative Key: 3

General Information About The Event

Date of event: 1992-02-20

Date initial reporter provided information: 1992-02-21

Number of devices in report:

Number of patients in report:

Suspected adverse outcome in a patient: Y

Report is about the quality, performance, or safety of a device: N

Source

Report source: User Facility report

Is reporter a health professional:

Initial reporter occupation:

Submitted copy of report to FDA:

Single-use device that was reprocessed and reused?:

Manufacturer Information

Name:

Country:

Location:

Contact Person:

Contact Person County:

Contact Address: ,

Contact Phone Number:

Contact Extention:

Device # 1 - N/a, Manual hospital bed

Device Event Key: 8

FDA Product Code Classification: FNJ

Model Number: 720

Catalog Number: N/A

Lot Number: N/A

Expiration Date of Device:

Age of Device:

Device Operator: Other Caregivers

Implanted?: N

Date Implanted Device Removed:

Evaluation By Manufacturer

Device Available For Evaluation: Yes

Date Returned to Manufacturer:

Device Evaluated By Manufacturer:

Remedial Action Taken At Time of Report: [""]

Removal Reporting Number:

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