FDA Adverse Event
Injury
Summary report: N
XENFORM
MDR report key: 2630760
·
Received June 22, 2012
Report
- Report Number
- 3004170064-2012-00013
- Event Type
- Injury
- Date Received
- June 22, 2012
- Report Date
- June 21, 2012
- Manufacturer
- TEI BIOSCIENCES INC.
- Product Code
- FTM
- PMA / PMN Number
- K060984
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PRODUCT INFO INCLUDING LOT NUMBER WERE NOT AVAILABLE, THEREFORE, NO DEVICE HISTORY RECORD COULD BE REVIEWED. NO ADDITIONAL INFO HAS BEEN MADE AVAILABLE. THIS IS A LEGAL CASE.
Description of Event or Problem · 1
THE ONLY INFO AVAILABLE ON THIS PT CAME FROM AN ATTORNEY, NOT A HEALTHCARE PROFESSIONAL. THE PT COMPLAINED OF SEVERE AND PERMANENT BODILY INJURIES AND SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING. IT IS PRESUMED THAT THE PT WAS TREATED WITH THE DEVICE, XENFORM, BUT DATE OF TREATMENT HAS NOT BEEN CONFIRMED BY A HEATLHCARE PROFESSIONAL. IT IS NOT KNOWN WHAT TREATMENT, IF ANY, THE PT HAS HAD AFTER THE PRESUMPTIVE TREATMENT WITH XENFORM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XENFORM | SURGICAL MESH | FTM | TEI BIOSCIENCES INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |