FDA Adverse Event
Summary report: N
URETEX SUP URETHRAL SUPPORT SYSTEM
MDR report key: 3152177
·
Received May 16, 2013
Report
- Report Number
- 1018233-2013-02038
- Date Received
- May 16, 2013
- Report Date
- April 16, 2013
- Manufacturer
- SOFRADIM PRODUCTIONS
- Product Code
- OTN
- 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. PER ADDITIONAL INFORMATION RECEIVED, THE PT HAS EXPERIENCED "A QUARTER OF THE BLADDER CAUGHT BY THE METAL PASSER" AFTER UNDERGOING CYSTOSCOPY; LEFT URETEROSCOPY AND SLING IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 216465 | URETEX SUP URETHRAL SUPPORT SYSTEM | OTN | SOFRADIM PRODUCTIONS | NA | C24016SUP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Required Intervention |