FDA Adverse Event
Injury
Summary report: N
URETEX PUBOVAGINAL SLING
MDR report key: 1032749
·
Received March 24, 2008
Report
- Report Number
- 1018233-2008-00020
- Event Type
- Injury
- Date Received
- March 24, 2008
- Date of Event
- February 21, 2008
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- FTL
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPERIENCED HEMATURIA BEGINNING IN 2008 FOLLOWING A URETHRAL SUPPORT PROCEDURE IN 2004, FOR STRESS URINARY INCONTINENCE. VIA CYSTOSCOPY, THE DR OBSERVED EROSION OF A SMALL PIECE OF MATERIAL AT THE MID-URETHRA ON THE PT'S RIGHT SIDE. IN 2008, THE DR UNSUCCESSFULLY ATTEMPTED TO CUT AND REMOVE THE PIECE WITH ENDOSCOPIC SCISSORS. HE ALSO UNSUCCESSFULLY ATTEMPTED TO REMOVE THE PIECE WITH A HOLMIUM LASER AT 20 WATTS. IF A TRANSURETHRAL ATTEMPT FAILS, THE DR WILL REMOVE THE SMALL PIECE TRANSVAGINALLY. THE PT WAS GIVEN KEFLEX POST-OPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | URETEX PUBOVAGINAL SLING | FTL | FTL | SOFRADIM PRODUCTION | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Required Intervention |