FDA Adverse Event
Other
Summary report: N
AVAULTA BIOSYNTHETIC SUPPORT SYSTEM
MDR report key: 5047690
·
Received February 8, 2013
Report
- Report Number
- 1018233-2013-00310
- Event Type
- Other
- Date Received
- February 8, 2013
- Report Date
- January 9, 2013
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- FTL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- ATTORNEY
- Health Professional
- N
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 55555 | AVAULTA BIOSYNTHETIC SUPPORT SYSTEM | FTL | SOFRADIM PRODUCTION | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention |