FDA Adverse Event
Injury
Summary report: N
PARIETEX UGYTEX PP ANTERIOR KIT X1
MDR report key: 2133715
·
Received June 9, 2011
Report
- Report Number
- 9615742-2011-00050
- Event Type
- Injury
- Date Received
- June 9, 2011
- Date of Event
- November 8, 2007
- Report Date
- December 7, 2015
- 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
- ATTORNEY
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4). MDR REF #: 9615742-2011-00049 (AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM).
Description of Event or Problem · 1
UROLOGICAL AND GYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PATIENT UNDERWENT A POSTERIOR REPAIR PROCEDURE FOR TREATMENT OF PELVIC ORGAN PROLAPSE. THE PATIENT ALLEGEDLY EXPERIENCED PAIN AND INJURY. PATIENT 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 BIOSYTH. SYSTEM | FTL | SOFRADIM PRODUCTION | ZGJ00364 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention| O |