FDA Adverse Event
Injury
Summary report: N
ARIS TRANS-OBTURATOR
MDR report key: 3763988
·
Received October 7, 2013
Report
- Report Number
- 2125050-2013-00338
- Event Type
- Injury
- Date Received
- October 7, 2013
- Date of Event
- May 24, 2011
- Report Date
- October 7, 2013
- Manufacturer
- COLOPLAST A/S
- Product Code
- FTL
- PMA / PMN Number
- K050148
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
COLOPLAST HAS BOT BEEN PROVIDED NAY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT.
Description of Event or Problem · 1
AS REPORTED TO COLOPLAST THOUGH NOT VERIFIED, PATIENT WAS IMPLANTED WITH ARIS MESH. LATER THE PATIENT EXPERIENCED INCONTINENCE, DYSURIA, BLEEDING, EXPOSED MESH, PAIN AND SECONDARY PROLAPSE. AN EXCISION OF THE EXPOSED MESH AND REPAIR OF VAGINAL VAULT WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 507401 | ARIS TRANS-OBTURATOR | POLYMERIC SURGICAL MESH | FTL | COLOPLAST A/S | 5195501000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |