FDA Adverse Event
Injury
Summary report: N
ARIS TRANS-OBTURATOR
MDR report key: 3840623
·
Received January 30, 2014
Report
- Report Number
- 2125050-2014-00123
- Event Type
- Injury
- Date Received
- January 30, 2014
- Date of Event
- October 19, 2012
- Report Date
- January 30, 2014
- Manufacturer
- COLOPLAST A/S
- Product Code
- OTN
- 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 MESH EXPOSURE, RECURRENT CYSTOCELE, VAGINAL VAULT PROLAPSE, URINARY FREQUENCY AND DYSPAREUNIA. AN EXCISION OF THE MESH, ANTERIOR REPAIR AND POSTERIOR REPAIR WITH COLOPLAST RESTORELLE Y MESH WERE PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 65489 | ARIS TRANS-OBTURATOR | POLYMERIC SURGICAL MESH | OTN | COLOPLAST A/S | 5195501000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |