FDA Adverse Event
Injury
Summary report: N
TENSION FREE VAGINAL TAPE
MDR report key: 2032702
·
Received March 17, 2011
Report
- Report Number
- 2210968-2011-00287
- Event Type
- Injury
- Date Received
- March 17, 2011
- Date of Event
- November 16, 2010
- Report Date
- February 14, 2011
- Manufacturer
- ETHICON, INC.
- Product Code
- FTL
- PMA / PMN Number
- K033568
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. 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 AN OBTURATOR SLING PROCEDURE, LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY, AND BILATERAL SALPINGO-OOPHORECTOMY WITH POSTERIOR COLPORRHAPHY ON (B)(6) 2010. ON (B)(6) 2010, THE PT EXPERIENCED PURULENT DISCHARGE AND HAD AN OPEN SLING INCISION. ON (B)(6) 2011, A HARD PLASTIC PIECE WAS PALPATED ON THE RIGHT SIDE AND THE TAPE WAS CUT AT THE MIDLINE AND THE SHEATH REMNANT WAS REMOVED VAGINALLY IN THE OFFICE.
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 | 55 YR | Required Intervention |