FDA Adverse Event
Injury
Summary report: N
OBTAPE TRANSOBTURATOR SLING
MDR report key: 3122487
·
Received May 8, 2013
Report
- Report Number
- 1645337-2013-00144
- Event Type
- Injury
- Date Received
- May 8, 2013
- Manufacturer
- MENTOR WORLDWIDE LLC
- Product Code
- OTN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE PT WAS IMPLANTED WITH AN OBTAPE TRANSOBTURATOR SLING. SUBSEQUENTLY, ACCORDING TO THE PT'S ATTORNEY, THE PT EXPERIENCED EROSION, INFECTION AND PAIN. NO OTHER INFO IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 200063 | OBTAPE TRANSOBTURATOR SLING | TRANSOBTURATOR | OTN | MENTOR WORLDWIDE LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |