FDA Adverse Event
Injury
Summary report: N
PARIETEX UGYTEX PP ANTERIOR KIT X1
MDR report key: 3001088
·
Received March 5, 2013
Report
- Report Number
- 9615742-2013-00156
- Event Type
- Injury
- Date Received
- March 5, 2013
- Date of Event
- July 23, 2007
- Report Date
- February 6, 2013
- 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
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4). BRAND NAME: AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM, CATALOG # 486010. (B)(6).
Description of Event or Problem · 1
PROCEDURE TYPE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. ADDITIONAL INFORMATION FROM IMPORTER REPORT - ASSOCIATED MDR: 1018233-2013-00692.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 93487 | PARIETEX UGYTEX PP ANTERIOR KIT X1 | AVAULTA ANTERIOR SYSTEM | FTL | SOFRADIM PRODUCTION | NA | ZGF00489 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Female | Required Intervention| O | PELVILACE BIOURETHRAL SUPPORT SYSTEM| PELVILACE BIOURETHRAL SUPPORT SYSTEM |