FDA Adverse Event
Injury
Summary report: N
AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM
MDR report key: 3213430
·
Received May 8, 2013
Report
- Report Number
- 1018233-2013-01772
- Event Type
- Injury
- Date Received
- May 8, 2013
- Report Date
- April 10, 2013
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- FTL
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- MO, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADD'L INFO HAS BEEN REQUESTED, BUT NOT YET REC'D. ASSOCIATED MDR: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 202494 | AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM | FTL | SOFRADIM PRODUCTION | NA | ZGD00283 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention | AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM| GYNECARE TVT |