FDA Adverse Event
Injury
Summary report: N
OBTAPE TRANSOBTURATOR SLING
MDR report key: 5886454
·
Received August 18, 2016
Report
- Report Number
- 1645337-2016-00040
- Event Type
- Injury
- Date Received
- August 18, 2016
- Report Date
- July 20, 2016
- Manufacturer
- MENTOR WW LLC
- Product Code
- PAH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
NOT RETURNED.
Description of Event or Problem · 1
INJURIES. (LITIGATION CASE). THIS MEDWATCH WAS ORIGINALLY CREATED VIA PAPER ON (B)(6) 2016.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 538817 | OBTAPE TRANSOBTURATOR SLING | TRANSOBTURATOR | PAH | MENTOR WW LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |