FDA Adverse Event
Other
Summary report: N
XENFORM
MDR report key: 3993632
·
Received July 28, 2014
Report
- Report Number
- 3004170064-2014-00184
- Event Type
- Other
- Date Received
- July 28, 2014
- Report Date
- July 25, 2014
- Manufacturer
- TEI BIOSCIENCES, INC.
- Product Code
- FTM
- PMA / PMN Number
- K060984
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
THIS IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE THE COMPLAINT ORIGINATED FROM AN ATTORNEY. IT IS NOT KNOWN WHAT THE PATIENT WAS ORIGINALLY TREATED FOR. ONE DEVICE WAS IMPLANTED ON (B)(6) 2012. NO ADDITIONAL INFORMATION WAS PROVIDED. THE COMPLAINT VIA THE ATTORNEY WAS THAT THE PATIENT SUFFERED AN INJURY, INCLUDING EROSION, MESH CONTRACTION, INFECTION, FISTULA, INFLAMMATION, SCAR TISSUE, ORGAN PERFORATION, DYSPAREUNIA, BLOOD LOSS, NEUROPATHIC NERVE DAMAGE, ACUTE AND CHRONIC NERVE PAIN, ADDITIONAL SURGICAL PROCEDURES. IT IS NOT KNOWN WHEN THE EVENT OCCURRED. IT IS NOT KNOWN WHAT THE PATIENT'S CURRENT CONDITION IS. NO INFORMATION HAS BEEN CONFIRMED BY A HEALTH CARE PROFESSIONAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 438840 | XENFORM | SURGICAL MESH | FTM | TEI BIOSCIENCES, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |