FDA Adverse Event
Injury
Summary report: N
ARIS TRANS-OBTURATOR
MDR report key: 3840708
·
Received January 30, 2014
Report
- Report Number
- 2125050-2014-00153
- Event Type
- Injury
- Date Received
- January 30, 2014
- Date of Event
- June 21, 2013
- Report Date
- January 30, 2014
- 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 NOT BEEN PROVIDED ANY 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 PATIENT EXPERIENCED SLOW AND STRAY URINARY STREAM, PELVIC PAIN AND DISCOMFORT, POSSIBLE CHRONIC REJECTION TO THE MESH, URINARY TRACT INFECTION, MESH EXPOSURE, DYSPAREUNIA, BLEEDING, SCARRING AND LOSS OF CONSORTIUM BY PARTNER. TRIMMING, MESH EXCISION AND A CYSTOSCOPY WERE PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 66380 | ARIS TRANS-OBTURATOR | PUBORUETHRAL SUPPORT TAPE | FTL | COLOPLAST A/S | 5195501000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |