FDA Adverse Event
Injury
Summary report: N
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REIN
MDR report key: 1133306
·
Received August 22, 2008
Report
- Report Number
- 3003910212-2008-00025
- Event Type
- Injury
- Date Received
- August 22, 2008
- Date of Event
- June 17, 2008
- Report Date
- August 22, 2008
- Manufacturer
- W.L. GORE & ASSOCIATES, INC.
- Product Code
- FTL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
REVIEW OF DEVICE HISTORY RECORD.
Description of Event or Problem · 1
THE PHYSICIAN REPORTED THE PT HAD BEEN TREATED WITH CIRCULAR BIOABSORBABLE SEARGUARD (CBSG). THE REPORT GOES ON TO SAY THAT, POST OP, CT SCAN SHOWED A FAIRLY SMALL PELVIC ABSCESS, IN THE PT, THAT WAS DRAINED WITH NO FURTHER PROBLEM. ADDITIONALLY, THE PHYSICIAN REPORTED THE EVENT DOESN'T APPEAR TO BE CBSG RELATED AND THE PT IS DOING OK. FURTHER INVESTIGATION IS PENDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REIN | CIRCULAR STAPLE LINE REINFORCEMENT | FTL | W.L. GORE & ASSOCIATES, INC. | WLG520 | 05892021 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |