FDA Adverse Event
Injury
Summary report: N
TENSION FREE VAGINAL TAPE
MDR report key: 1822859
·
Received August 30, 2010
Report
- Report Number
- 2210968-2010-01009
- Event Type
- Injury
- Date Received
- August 30, 2010
- Report Date
- August 6, 2010
- Manufacturer
- ETHICON, INC.
- Product Code
- FTL
- PMA / PMN Number
- K033568
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(6). NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE BETWEEN (B)(6) 2007 AND (B)(6) 2009. THE PATIENT PRESENTED WITH A MESH EROSION BY TWELVE WEEKS POST-PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED RELATING TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TENSION FREE VAGINAL TAPE | MESH, SURGICAL, POLYMERIC | FTL | ETHICON, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |