FDA Adverse Event
Injury
Summary report: N
DESARA
MDR report key: 3012389
·
Received March 7, 2013
Report
- Report Number
- 3003990090-2013-00036
- Event Type
- Injury
- Date Received
- March 7, 2013
- Report Date
- February 13, 2013
- Manufacturer
- CALDERA MEDICAL, INC.
- Product Code
- FTL
- PMA / PMN Number
- UNK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
EVENT WAS REPORTED TO CALDERA MEDICAL BY AN ATTORNEY. LEGAL COMPLAINT STATES THAT PT SUFFERED EXCRUCIATING PAIN, LACERATION OF AND DAMAGE TO INTERNAL BODILY TISSUE AND ORGANS, EROSION, ABRASION, AND GRANTING OF INTERNAL BODILY TISSUE AND ORGANS, DYSPAREUNIA, DYSURIA, SEVERE EDEMA, EXTRUSION, BLEEDING, PERMANENT SCARRING, PERMANENT BODILY IMPAIRMENT AND RELATED SEQUELAE RESULTING IN SUBSTANTIAL INTERFERENCE WITH PLAINTIFF ABILITY TO ENGAGE IN ROUTINE DAILY ACTIVITIES AND SPORTING ACTIVITIES THAT SHE PREVIOUSLY ENJOYED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 98534 | DESARA | SURGICAL MESH | FTL | CALDERA MEDICAL, INC. | CAL-DS01 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |