FDA Adverse Event
Injury
Summary report: N
OBTAPE SLING
MDR report key: 900136
·
Received August 10, 2007
Report
- Report Number
- 1645337-2007-00011
- Event Type
- Injury
- Date Received
- August 10, 2007
- Report Date
- August 9, 2007
- Manufacturer
- MENTOR
- Product Code
- FTL
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
VAGINAL EROSION, EXTRUSION, DEHISCENCE AND INFECTION ARE KNOWN COMPLICATIONS ASSOCIATED WITH THE USE OF BOTH SYNTHETIC AND ANTILOGOUS/DONOR TISSUE PUB-VAGINAL SLINGS FOR TREATMENT OF URINARY INCONTINENCE, SURGICAL TECHNIQUE VARIABLES, AND A HISTORY OF PREVIOUS OR CONCURRENT UROGYNECOLOGY SURGICAL PROCEDURES CAN AFFECT THE RATE OF THIS OCCURRENCE. IN ADDITION, PRE-EXISTING CO-MORBIDITIES THAT AFFECT HEALING SUCH AS OBESITY, HYPERTENSION, IMMUNOSUPPRESSION, DIABETES, RECURRENT VAGINAL OR URINARY TRACT INFECTIONS, AND POST-MENOPAUSAL VAGINAL MUCOSAL CHANGES CAN CONTRIBUTE TO AN INCREASED INCIDENCE OF THESE EVENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OBTAPE SLING | FTL | MENTOR | 93-4000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |