FDA Adverse Event
Injury
Summary report: N
PARIETEX UGYTEX PP ANTERIOR KIT X1
MDR report key: 2901231
·
Received November 21, 2012
Report
- Report Number
- 9615742-2012-00578
- Event Type
- Injury
- Date Received
- November 21, 2012
- Date of Event
- July 25, 2008
- Report Date
- October 26, 2012
- 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
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ADDITIONAL INFO: DATE OF THIS REPORT: (B)(4) 2012. (B)(6).
Description of Event or Problem · 1
PROCEDURE: UROLOGICAL/GYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT UNDERWENT A REPAIR PROCEDURE AND THE PT ALLEGEDLY EXPERIENCED PAIN AND INJURY. PT HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES. THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDRS# 1018233-2012-01725, 1018233-2012-01728, AND 1018233-2012-01727.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PARIETEX UGYTEX PP ANTERIOR KIT X1 | AVAULTA ANTERIOR SYSTEM | OTP | SOFRADIM PRODUCTION | NA | ZGI00399 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Female | Required Intervention | ALIGN S URETHRAL SUPPORT SYSTEM| AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM| PELVISOFT ACELLULAR COLLAGEN BIOMESH | AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM| ALIGN S URETHRAL SUPPORT SYSTEM| PELVISOFT ACELLULAR COLLAGEN BIOMESH |