FDA Adverse Event
Injury
Summary report: N
POSTERIOR VAGINAL MESH
MDR report key: 3934330
·
Received July 10, 2014
Report
- Report Number
- MW5037237
- Event Type
- Injury
- Date Received
- July 10, 2014
- Date of Event
- June 6, 2014
- Report Date
- July 9, 2014
- Product Code
- OTN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
PRIOR POSTERIOR VAGINAL MESH. AS A NEW PATIENT WAS FOUND TO HAVE EROSION AND DEALT WITH DYSPAREUNIA. SHE DESIRED SURGICAL REMOVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 402513 | POSTERIOR VAGINAL MESH | VAGINAL MESH | OTN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Hospitalization |