FDA Adverse Event
Injury
Summary report: N
GORE-TEX SOFT TISSUE PATCH
MDR report key: 1962518
·
Received January 7, 2011
Report
- Report Number
- 2017233-2011-00005
- Event Type
- Injury
- Date Received
- January 7, 2011
- Date of Event
- December 10, 2010
- Report Date
- January 5, 2011
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- FTL
- PMA / PMN Number
- K963619
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS IN PROGRESS.
Description of Event or Problem · 1
IT WAS REPORTED TO GORE THAT A PT UNDERWENT A HERNIA REPAIR IN 1984 IN WHICH GORE-TEX SOFT TISSUE PATCH WAS USED. THE SURGEON INDICATED THAT IN 2008 THE PT HAD AN ABSCESS AT THE SURGICAL SITE WHICH RECURRED IN (B)(6), 2010 AND THE DEVICE WAS REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE-TEX SOFT TISSUE PATCH | FTL / MESH, SURGICAL , POLYMERIC | FTL | W.L. GORE & ASSOCIATES | WLG101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |