FDA Adverse Event
Injury
Summary report: N
AVAULTA BIOSYNTHETIC SUPPORT SYSTEM- ANTERIOR
MDR report key: 1932691
·
Received November 19, 2010
Report
- Report Number
- 1018233-2010-00126
- Event Type
- Injury
- Date Received
- November 19, 2010
- Report Date
- October 29, 2010
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- FTL
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- NJ, US
- Reporter Occupation
- NOT APPLICABLE
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AVAULTA BIOSYNTHETIC SUPPORT SYSTEM- ANTERIOR | FTL | FTL | SOFRADIM PRODUCTION | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |