FDA Adverse Event
Injury
Summary report: N
URETEX SUPPORT PP KIT X1
MDR report key: 3170501
·
Received June 12, 2013
Report
- Report Number
- 9615742-2013-00564
- Event Type
- Injury
- Date Received
- June 12, 2013
- Date of Event
- December 22, 2006
- Report Date
- April 27, 2018
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- OTN
- PMA / PMN Number
- K012949
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 265608 | URETEX SUPPORT PP KIT X1 | URETEX SUPPORT | OTN | SOFRADIM PRODUCTION | SGI0004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Female | Other | URETEX SUP URETHRAL SUPPORT SYSTEM: PRODUCT # 485013, LOT # SGI0004, EXP: 09/30/2011, MFR DATE: 09/2006| PRODUCT # 485013, LOT # SGI0004| URETEX SUP URETHRAL SUPPORT SYSTEM: |