FDA Adverse Event
Injury
Summary report: N
PARIETEX UGYTEX PP POSTERIOR KIT X1
MDR report key: 3001098
·
Received March 5, 2013
Report
- Report Number
- 9615742-2013-00167
- Event Type
- Injury
- Date Received
- March 5, 2013
- Date of Event
- February 9, 2006
- Report Date
- May 4, 2018
- 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 BIOSYNTHETIC SUPPORT SYSTEM, CATALOG: UNKNOWN, LOT: UNK; (B)(6).
Description of Event or Problem · 1
PROCEDURE TYPE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. ADDITIONAL INFO FROM THE IMPORTER REPORT: ADDITIONAL INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR: 1018233-2013-00571.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 93470 | PARIETEX UGYTEX PP POSTERIOR KIT X1 | AVAULTA POSTERIOR SYSTEM | FTL | SOFRADIM PRODUCTION | NA | ZFH00269 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Female | Required Intervention| O | AVAULTA BIOSYNTHETIC SUPPORT SYSTEM| EXP: | OBTRYX TRANSOBTURATOR MID-URETHRAL SLING SYSTEM| PARIETEX UGYTEX PP ANTERIOR KIT X1| UGYKA, ZFK00012, K051503| EXP:| OBTRYX TRANSOBTURATOR MID-URETHRAL SLING SYSTEM| AVAULTA BIOSYNTHETIC SUPPORT SYSTEM| PARIETEX UGYTEX PP ANTERIOR KIT X1| UGYKA, ZFK00012, K051503 |