FDA Adverse Event
Injury
Summary report: N
TENSION FREE VAGINAL TAPE
MDR report key: 3161634
·
Received June 11, 2013
Report
- Report Number
- 2210968-2013-06951
- Event Type
- Injury
- Date Received
- June 11, 2013
- Report Date
- May 20, 2013
- Manufacturer
- ETHICON, INC.
- Product Code
- FTL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). CALCULI OCCURED. URINARY RETENTION OCCURED. 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 WITH A PROLAPSE REPAIR. THE PATIENT EXPERIENCED VOIDING DIFFICULTY AND RECURRENT URINARY TRACT INFECTIONS. A SMALL CALCULI WAS SEEN IN THE PROXIMAL URETHRA ON CYSTOSCOPY. IT WAS NOT SEEN ON EUA, BUT THE SLING WAS TIGHT. THE PATIENT UNDERWENT A DIVISION OF THE MESH AND AN EXCISION OF THE SUBURETHRAL PORTION OF MESH. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 261850 | TENSION FREE VAGINAL TAPE | MESH, SURGICAL, POLYMERIC | FTL | ETHICON, INC. | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |