FDA Adverse Event
Injury
Summary report: N
OBTAPE TRANSOBTURATOR SLING
MDR report key: 2801694
·
Received October 12, 2012
Report
- Report Number
- 1645337-2012-00204
- Event Type
- Injury
- Date Received
- October 12, 2012
- Report Date
- October 12, 2012
- Manufacturer
- MENTOR WORLDWIDE LLC
- Product Code
- FTL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT EXPERIENCED PAIN, EROSION, UTIS AND OTHER INJURIES AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OBTAPE TRANSOBTURATOR SLING | TRANSOBTURATOR | FTL | MENTOR WORLDWIDE LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |