FDA Adverse Event
Summary report: N
POLYSORB
MDR report key: 1180363
·
Received September 26, 2008
Report
- Report Number
- 1180363
- Date Received
- September 26, 2008
- Date of Event
- September 26, 2008
- Report Date
- September 26, 2008
- Manufacturer
- COVIDIEN (UNITED STATES SURGICAL CORP).
- Product Code
- GAM
- Report Source
- User Facility report
- Reporter Location
- VT, US
Narratives
Description of Event or Problem · 1
SURGEON REPORTED: OVER THE PAST YEAR, SURGEON HAD SEEN A TOTAL OF 7 PATIENTS - STATUS POST OP ~6 WEEKS - WHOSE INCISION SITES WERE "SPITTING SUTURES". I.E. SUBCUTICULAR SUTURE MATERIAL WAS BEING REJECTED. IN TWO CASES, THE SURGEON CULTURED THE MATERIAL RESULTING IN CULTURE POSITIVE FOR STREP AUREUS (NON-MRSA). SURGEON REPORTED THAT 3 OF THESE PATIENTS WERE SEEN (AT 6 WEEKS POST-UP) JUST WITHIN THE LAST WEEK OR SO. ALL PATIENTS WERE EITHER LAP CHOLE OR LAP APPENDECTOMY PATIENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POLYSORB | SUTURE, ABSORBABLE | GAM | COVIDIEN (UNITED STATES SURGICAL CORP). | * | UNKOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |