FDA Adverse Event
Injury
Summary report: N
OBTAPE SLING
MDR report key: 1211707
·
Received October 21, 2008
Report
- Report Number
- 1645337-2008-00050
- Event Type
- Injury
- Date Received
- October 21, 2008
- Report Date
- October 17, 2008
- Manufacturer
- MENTOR
- Product Code
- FTL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE PATIENT WAS IMPLANTED WITH AN OBTAPE TRANSOBTURATOR SLING. SUBSEQUENTLY, AS REPORTED BY HER ATTORNEY, THE PATIENT EXPERIENCED EROSION OF INTERNAL TISSUE INCLUDING EROSION THROUGH THE VAGINAL WALLS. NO OTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OBTAPE SLING | TRANSOBTURATOR SLING | FTL | MENTOR | 93-4000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |