FDA Adverse Event
Death
Summary report: N
PROLENE POLYPROPYLENE SUTURE
MDR report key: 502763
·
Received December 23, 2003
Report
- Report Number
- 2210968-2003-00513
- Event Type
- Death
- Date Received
- December 23, 2003
- Date of Event
- November 17, 2003
- Report Date
- December 1, 2003
- Manufacturer
- ETHICON, INC., SAN LORENZO
- Product Code
- GAW
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PT UNDERWENT A LEFT CAROTID ENDARTERECTOMY IN 2003. THREE DAYS LATER, THE PT WAS RETURNED TO OR DUE TO A REPORTED RUPTURED SUTURE LINE. IT WAS REPORTED THAT THE SUTURE WAS BROKEN IN THE MIDDLE OF THE RUNNING LONGITUDINAL SUTURE LINE. THE LEFT CAROTID WAS REPAIRED. PT WAS SENT TO RECOVERY FOLLOWING REPAIR. THE PT EXPIRED 3 WEEKS LATER FROM A CEREBRAL STROKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROLENE POLYPROPYLENE SUTURE | SUTURE, NON-ABSORBABLE | GAW | ETHICON, INC., SAN LORENZO | NA | SAE436 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Death |