FDA Adverse Event
Injury
Summary report: N
PARIETEX UGYTEX PP ANTERIOR KIT X1
MDR report key: 3001013
·
Received February 28, 2013
Report
- Report Number
- 9615742-2013-00141
- Event Type
- Injury
- Date Received
- February 28, 2013
- Date of Event
- March 6, 2008
- Report Date
- February 4, 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
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
(B)(4): AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM, CATALOG# 486010, (B)(6).
Description of Event or Problem · 1
PROCEDURE TYPE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PATIENT'S ATTORNEY HAS ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. THE PATIENT'S ATTORNEY HAS ALLEGED A DEFICIENCY AGAINST THE DEVICE. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED MINIMAL VAGINAL BLEEDING, MILD URGENCY, MILD FREQUENCY, RECTOCELE (GRADE 2/4), MODERATE PELVIC TONE, INCONTINENCE-URINARY AND FECAL, INCREASED NOCTURIA. OVERACTIVE BLADDER, MESH EXPOSURE, SMALL RECTOCELE, VAGINAL DISCOMFORT, ABDOMINAL TENDERNESS WITH PALPATION, MODERATE VAGINAL ATROPHY, AND ATROPHIC VAGINITIS. ASSOCIATED MDR: 1018233-2009-00095.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 86967 | PARIETEX UGYTEX PP ANTERIOR KIT X1 | AVAULTA ANTERIOR SYSTEM | FTL | SOFRADIM PRODUCTION | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Other| R | AVAULTA PLUS ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM |