FDA Adverse Event
Injury
Summary report: N
URETEX SUP URETHRAL SUPPORT SYSTEM
MDR report key: 3221150
·
Received May 17, 2013
Report
- Report Number
- 1018233-2013-02080
- Event Type
- Injury
- Date Received
- May 17, 2013
- Report Date
- April 18, 2013
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- FTL
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- TX, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
(B)(4). THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 219890 | URETEX SUP URETHRAL SUPPORT SYSTEM | FTL | SOFRADIM PRODUCTION | NA | C23163SUP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Required Intervention | DAVOL PTFE MESH |