FDA Adverse Event
Injury
Summary report: N
AVAULTA BIOSYNTHETIC SUPPORT SYSTEM
MDR report key: 2933264
·
Received January 16, 2013
Report
- Report Number
- 1018233-2013-00086
- Event Type
- Injury
- Date Received
- January 16, 2013
- Report Date
- December 18, 2012
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- FTL
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- CA, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
THIS MDR IS BEING FILED IN ASSOCIATION WITH THE ALLEGED EVENT FILED BY THE PATIENT'S ATTORNEY IN MDR # 101233-2013-00084 AND 1018233-2013-00085. THERE HAVE BEEN NO ALLEGATIONS OF DEFICIENCY OR SERIOUS INJURY AGAINST THIS DEVICE. THIS DEVICE IS LISTED IN THE PATIENT'S PROGRESS NOTES. ASSOCIATED MDRS: 1018233-2013-00084 AND 1018233-2013-00085.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 24976 | AVAULTA BIOSYNTHETIC SUPPORT SYSTEM | FTL | SOFRADIM PRODUCTION | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention | URETEX TO2 URETHRAL SUPPORT SYSTEM W/HOOK NEEDLE| AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM |