FDA Adverse Event
Death
Summary report: N
SURGICAL STAINLESS STEEL SUTURE
MDR report key: 763942
·
Received September 21, 2006
Report
- Report Number
- 2210968-2006-00622
- Event Type
- Death
- Date Received
- September 21, 2006
- Date of Event
- August 16, 2006
- Report Date
- August 22, 2006
- Manufacturer
- ETHICON, INC.
- Product Code
- GAQ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SU
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED. THIS REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.
Description of Event or Problem · 1
INTERNATIONAL CUSTOMER REPORTED THAT A PT PRESENTED WITH AN UNSTABLE STERNUM IN 2006, FOLLOWING A MITRAL VALVE PROCEDURE PERFORMED EIGHT DAYS EARLIER. THE PT WAS RETURNED TO SURGERY FOR REPAIR. PT SUBSEQUENTLY EXPIRED TWO DAYS LATER DUE TO STROKE SECONDARY TO HYPOXIA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SURGICAL STAINLESS STEEL SUTURE | SUTURE, NON-ABSORBABLE | GAQ | ETHICON, INC. | NA | ULR388 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Death |