FDA Adverse Event
Injury
Summary report: N
CIRCULAR BIOABSORBABLE SEAMGUARD
MDR report key: 1211760
·
Received October 24, 2008
Report
- Report Number
- 3003910212-2008-00042
- Event Type
- Injury
- Date Received
- October 24, 2008
- Date of Event
- September 25, 2008
- Report Date
- October 24, 2008
- Manufacturer
- W.L. GORE & ASSOCIATES, INC
- Product Code
- FTL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
METHOD - INVESTIGATION IS IN PROGRESS.
Description of Event or Problem · 1
IT WAS REPORTED TO GORE, THE GORE BIOABSORBABLE SEAMGUARD WAS IMPLANTED DURING A SIGMOIDECTOMY IN 2008. THE PATIENT WAS READMITTED ABOUT THREE DAYS LATER FOR PAIN. RE-INTERVENTION OCCURRED IN THE NEXT DAY, AND THE PHYSICIAN DISCOVERED 2 SMALL HOLES AT THE ANASTOMOSIS. THE PHYSICIAN REPAIRED THE HOLES, AND PERFORMED AN ABDOMINAL WASHOUT OF THE PATIENT. ADDITIONALLY, THE PATIENT RECEIVED A TEMPORARY ILEOSTOMY. ACCORDING TO THE PHYSICIAN, THE PATIENT IS OK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CIRCULAR BIOABSORBABLE SEAMGUARD | NONE | FTL | W.L. GORE & ASSOCIATES, INC | WLG520 | 05939703 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Required Intervention |