FDA Adverse Event
Injury
Summary report: N
ARIS TRANS-OBTURATOR KIT
MDR report key: 3120137
·
Received May 20, 2013
Report
- Report Number
- 2125050-2013-00046
- Event Type
- Injury
- Date Received
- May 20, 2013
- Report Date
- May 20, 2013
- Manufacturer
- COLOPLAST A/S
- Product Code
- FTL
- PMA / PMN Number
- K050148
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT. DEVICE NOT RETURNED.
Description of Event or Problem · 1
AS REPORTED TO COLOPLAST THOUGH NOT VERIIFED, PATIENT IMPLANTED WITH PRODUCT OR ABOUT (B)(6) 2008. LATER PATIENT EXPERIENCED PAIN, PERMANENT INJURY, AUTOIMMUNE DISORDER AND WILL LIKELY UNDERGO CORRECTIVE SURGERY AND HAS ENDURED IMPAIRED PHYSICAL RELATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 222379 | ARIS TRANS-OBTURATOR KIT | PUBORUETHRAL SUPPORT TAPE | FTL | COLOPLAST A/S | 5195501000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |