FDA Adverse Event
Injury
Summary report: N
URETEX TO2 URETHRAL SUPPORT SYSTEM
MDR report key: 3152158
·
Received May 29, 2013
Report
- Report Number
- 1018233-2013-02264
- Event Type
- Injury
- Date Received
- May 29, 2013
- Report Date
- April 29, 2013
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- OTN
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- CO, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
(B)(4). THE PT'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 |
|---|---|---|---|---|---|---|---|
| 233693 | URETEX TO2 URETHRAL SUPPORT SYSTEM | OTN | SOFRADIM PRODUCTION | NA | SFK00448 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Required Intervention |