FDA Adverse Event
Injury
Summary report: N
GORE DUALMESH BIOMATERIAL WITH CORDUROY TIS
MDR report key: 1003015
·
Received February 25, 2008
Report
- Report Number
- 2017233-2008-00082
- Event Type
- Injury
- Date Received
- February 25, 2008
- Date of Event
- January 29, 2008
- Report Date
- February 22, 2008
- Manufacturer
- W. L. GORE & ASSOCIATES, INC.
- Product Code
- FTL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS CURRENTLY ONGOING.
Description of Event or Problem · 1
IT WAS REPORTED TO GORE BY THE SURGEON, IN A CASE WITH GORE DUALMESH BIOMATERIAL WITH CORDUROY SURFACE, HE OBSERVED "LIQUID" AROUND THE MATERIAL DESCRIBED AS A "THICK GREEN FLUID". THE SURGEON REPORTED THAT THE FLUID WAS STERILE AND CONTAINED NO BACTERIA. THE DEVICE WAS EXPLANTED. THE SURGEON MENTIONED THAT HE RECALLS SIMILAR OCCURRENCES FOUR TIMES PREVIOUSLY. THE SURGEON TOLD GORE HE HAD PROBLEMS WITH POLYESTER SUTURES AND GORE DUALMESH BIOMATERIAL WITH CORDUROY SURFACE BECAUSE OF PAIN AND INFECTIONS OF THE AREA WHERE THE SUTURES HAD BEEN. NO EXPLANT IS AVAILABLE FOR EXAMINATION. THE INVESTIGATION IS ONGOING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE DUALMESH BIOMATERIAL WITH CORDUROY TIS | PATCH | FTL | W. L. GORE & ASSOCIATES, INC. | WLG101 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Required Intervention |