FDA Adverse Event
Injury
Summary report: N
AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM
MDR report key: 3172213
·
Received April 24, 2013
Report
- Report Number
- 1018233-2013-01526
- Event Type
- Injury
- Date Received
- April 24, 2013
- Report Date
- March 25, 2013
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- FTL
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- NJ, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY THE PT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PT HAS EXPERIENCED PAIN, DISABILITY AND IMPAIRMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 178077 | AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM | FTL | SOFRADIM PRODUCTION | NA | ZGE00368 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | CALDERA MEDICAL T-SLING |