FDA Adverse Event
Other
Summary report: N
AVAULTA POSTERTOR BIOSYNTHETIC SUPPORT SYSTEM
MDR report key: 6990111
·
Received October 31, 2017
Report
- Report Number
- 1018233-2012-02204
- Event Type
- Other
- Date Received
- October 31, 2017
- Report Date
- December 11, 2012
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- FTL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- ATTORNEY
- Health Professional
- N
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 771864 | AVAULTA POSTERTOR BIOSYNTHETIC SUPPORT SYSTEM | FTL | SOFRADIM PRODUCTION | NA | ZGG00609 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention | AVAULTA ANTERIOR BIOSYNTLSETTC SUPPORT SYSTEM AND URETEX TO2.| HOOK NEEDLE.| URETHRAL SUPPORT SYSTEM WITH. |