FDA Adverse Event
Injury
Summary report: N
PARIETEX UGYTEX PP ANTERIOR KIT X1
MDR report key: 2234089
·
Received August 29, 2011
Report
- Report Number
- 9615742-2011-00077
- Event Type
- Injury
- Date Received
- August 29, 2011
- Date of Event
- April 7, 2009
- Report Date
- July 27, 2011
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- FTL
- PMA / PMN Number
- K051503
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: UROLOGICAL & GYNECOLOGICAL. ACCORDING TO REPORTER: THE PT UNDERWENT AN ANTERIOR REPAIR PROCEDURE FOR TREATMENT OF A PELVIC ORGAN PROLAPSE. THE PT ALLEGEDLY EXPERIENCED PAIN AND INJURY. PT HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PARIETEX UGYTEX PP ANTERIOR KIT X1 | AVAULTA ANTERIOR BIOSYNTH SYSTEM | FTL | SOFRADIM PRODUCTION | ZHI00366 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Other| R |