FDA Adverse Event
Injury
Summary report: N
URETEX SUP URETHRAL SUPPORT SYSTEM
MDR report key: 3203804
·
Received April 11, 2013
Report
- Report Number
- 1018233-2013-01272
- Event Type
- Injury
- Date Received
- April 11, 2013
- Report Date
- March 12, 2013
- Manufacturer
- SOFRADIM PRODUCTIONS
- Product Code
- OTN
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- NY, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADD'L INFO HAS BEEN REQUESTED. BUT NOT YET RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 157088 | URETEX SUP URETHRAL SUPPORT SYSTEM | OTN | SOFRADIM PRODUCTIONS | NA | C24026SUP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Required Intervention |