FDA Adverse Event
Injury
Summary report: N
TENSION FREE VAGINAL TAPE
MDR report key: 1033808
·
Received April 24, 2008
Report
- Report Number
- 2210968-2008-00274
- Event Type
- Injury
- Date Received
- April 24, 2008
- Report Date
- March 24, 2008
- Manufacturer
- ETHICON, INC.
- Product Code
- FTL
- PMA / PMN Number
- K052401
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: THE PHYSICIAN OPINED THAT THE PROBABLE SOURCE OF THE INJURY WAS THAT HE MADE THE SUBURETHRAL INCISION TWO CENTIMETERS LONG INSTEAD OF TWO CENTIMETERS DEEP.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING DISSECTION FOR A SLING PROCEDURE, THE SURGEON PERFORATED THE BLADDER. THE BLADDER WAS REPAIRED, INDIGO CARMINE WAS GIVEN, AND BOTH URETERS WERE FINE. IT WAS REPORTED THAT THIS WAS THE PHYSICIAN'S FIRST PROCEDURE WITH THE DEVICE. THE PHYSICIAN OPINED THAT THE PROBABLE SOURCE OF THE INJURY WAS THAT HE HAD MADE THE SUBURETHRAL INCISION TWO CENTIMETERS LONG INSTEAD OF TWO CENTIMETERS DEEP. THE DEVICE WAS NOT PLACED, BUT A KELLY PLICATION WAS CARRIED OUT WITH CATHETER DRAINAGE FOR TEN DAYS. THE PATIENT IS NOW DOING WELL.
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 | Required Intervention |