FDA Adverse Event
Malfunction
Summary report: N
TENSION FREE VAGINAL TAPE
MDR report key: 1990063
·
Received January 28, 2011
Report
- Report Number
- 2210968-2011-00083
- Event Type
- Malfunction
- Date Received
- January 28, 2011
- Date of Event
- December 28, 2010
- Report Date
- December 29, 2010
- Manufacturer
- ETHICON, INC.
- Product Code
- FTL
- PMA / PMN Number
- K012628
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). CONCLUSION: SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT UNDERWENT A SLING PROCEDURE ON (B)(6) 2010. DURING THE END OF THE PROCEDURE, THE SURGEON CUT THE SHEATH TOO CLOSE TO THE SKIN INCISION. THE SHEATH "SPRANG" BACK INTO THE PT'S ABDOMEN. THE SURGEON SEARCHED FOR THE SHEATH WITH NO RESULTS. THE SURGEON THEN REMOVED THE MESH ENTIRELY BUT NO SHEATH WAS LOCATED.
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 |