FDA Adverse Event
Injury
Summary report: N
URETEX SUPPORT PP KIT X1
MDR report key: 3040254
·
Received March 26, 2013
Report
- Report Number
- 9615742-2013-00215
- Event Type
- Injury
- Date Received
- March 26, 2013
- Date of Event
- November 14, 2005
- Report Date
- February 27, 2013
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- FTL
- PMA / PMN Number
- K012949
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BRAND NAME: URETEX SUP URETHRAL SUPPORT SYSTEM. CATALOG # 485013. (B)(6).
Description of Event or Problem · 1
PROCEDURE TYPE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. ADDITIONAL INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR: 1018233-2013-00977.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 123886 | URETEX SUPPORT PP KIT X1 | URETEX SUPPORT | FTL | SOFRADIM PRODUCTION | NA | SFD00174 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Other| R | PELVISOFT ACELLULAR COLLAGEN BIOMESH| URETEX SUP URETHRAL SUPPORT SYSTEM |