FDA Adverse Event
Injury
Summary report: N
URETEX SUP URETHRAL SUPPORT SYSTEM
MDR report key: 3192766
·
Received April 26, 2013
Report
- Report Number
- 1018233-2013-01605
- Event Type
- Injury
- Date Received
- April 26, 2013
- Report Date
- March 29, 2013
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- OTN
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- FL, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 183447 | URETEX SUP URETHRAL SUPPORT SYSTEM | OTN | SOFRADIM PRODUCTION | NA | SGA00717 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM| AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM |