FDA Adverse Event
Injury
Summary report: N
URETEX SUPPORT PP KIT X1
MDR report key: 3131042
·
Received May 21, 2013
Report
- Report Number
- 9615742-2013-00464
- Event Type
- Injury
- Date Received
- May 21, 2013
- Date of Event
- September 20, 2004
- Report Date
- April 26, 2013
- 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 TYPE: STRESS URINARY INCONTINENCE. ACCORDING TO THE REPORTER: THE PATIENT'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 |
|---|---|---|---|---|---|---|---|
| 225354 | URETEX SUPPORT PP KIT X1 | URETEX SUPPORT | OTN | SOFRADIM PRODUCTION | 04B10-2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Female | Other | 6X8CM/1.0MM PELVISOFT, 481068, LOT #: 04B10-2| 6X8CM/1.0MM PELVISOFT, 481068, LOT #: 04B10-2 |