FDA Adverse Event
Injury
Summary report: N
AVAULTA BIOSYNTHETIC SUPPORT SYSTEM - POSTERIOR
MDR report key: 2022523
·
Received January 28, 2011
Report
- Report Number
- 1018233-2011-00007
- Event Type
- Injury
- Date Received
- January 28, 2011
- Report Date
- December 29, 2010
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- FTL
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- FL, 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 IN HER, THE PT HAS EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, HAS SUSTAINED PERMANENT INJURY, PERMANENT AND SUBSTANTIAL PHYSICAL DEFORMITY, AND LOSS OF A BODILY ORGAN SYSTEM, HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES, AND HAS ENDURED IMPAIRED PHYSICAL RELATIONS WITH HER HUSBAND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AVAULTA BIOSYNTHETIC SUPPORT SYSTEM - POSTERIOR | FTL | FTL | SOFRADIM PRODUCTION | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |