FDA Adverse Event
Injury
Summary report: N
OBTAPE TRANSOBTURATOR SLING
MDR report key: 5883819
·
Received August 17, 2016
Report
- Report Number
- 1645337-2016-00121
- Event Type
- Injury
- Date Received
- August 17, 2016
- Report Date
- August 15, 2016
- Manufacturer
- MENTOR WW LLC
- Product Code
- PAH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
NOT RETURNED.
Description of Event or Problem · 1
INJURIES. (LITIGATION CASE).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 535280 | OBTAPE TRANSOBTURATOR SLING | TRANSOBTURATOR | PAH | MENTOR WW LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |