FDA Adverse Event
Injury
Summary report: N
PARIETEX UGYTEX PP ANTERIOR KIT X1
MDR report key: 3231652
·
Received July 12, 2013
Report
- Report Number
- 9615742-2013-00799
- Event Type
- Injury
- Date Received
- July 12, 2013
- Date of Event
- March 26, 2007
- Report Date
- June 19, 2013
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- OTP
- PMA / PMN Number
- K051503
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TRACKING NUMBER (B)(4). COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4) (IMPORTER).
Description of Event or Problem · 1
PROCEDURE: STRESS UI / PELVIC ORGAN PROLAPSE. 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 |
|---|---|---|---|---|---|---|---|
| 324164 | PARIETEX UGYTEX PP ANTERIOR KIT X1 | AVAULTA ANTERIOR SYSTEM | OTP | SOFRADIM PRODUCTION | ZGH00267 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Other | AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM| PROD# 485013, LOT # SGI00812| PROD# 486010 | URETEX SUP URETHRAL SUPPORT SYSTEM| PROD# 486010| PROD# 485013, LOT # SGI00812| URETEX SUP URETHRAL SUPPORT SYSTEM| AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM |