FDA Adverse Event
Injury
Summary report: N
PARIETEX UGYTEX PP ANTERIOR KIT X1
MDR report key: 2903142
·
Received October 18, 2012
Report
- Report Number
- 9615742-2012-00511
- Event Type
- Injury
- Date Received
- October 18, 2012
- Report Date
- September 19, 2012
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- FTL
- 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
(B)(4). ADDITIONAL INFORMATION: DATE OF THIS REPORT: (B)(4) 2012, DEVICE INFO: AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM; CATALOG # 486010, (B)(6).
Description of Event or Problem · 1
PROCEDURE: UROLOGICAL/GYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PATIENT UNDERWENT A REPAIR PROCEDURE AND THE PATIENT ALLEGEDLY EXPERIENCED PAIN AND INJURY. PATIENT HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES. THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PARIETEX UGYTEX PP ANTERIOR KIT X1 | AVAULTA ANTERIOR SYSTEM | FTL | SOFRADIM PRODUCTION | NA | ZGA00010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Other| R | AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM| URETEX TO2 URETHRAL SUPPORT SYSTEM W/HOOK NEEDLE |