FDA Adverse Event
Injury
Summary report: N
ARIS TRANS-OBTURATOR
MDR report key: 3840763
·
Received January 30, 2014
Report
- Report Number
- 2125050-2014-00130
- Event Type
- Injury
- Date Received
- January 30, 2014
- Date of Event
- January 5, 2007
- 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 INFO CONTAINED IN THIS REPORT.
Description of Event or Problem · 1
AS REPORTED TO COLOPLAST THOUGH NOT VERIFIED, PT WAS IMPLANTED WITH ARIS MESH. LATER PT EXPERIENCED MESH EROSION, VAGINAL DISCHARGE, DYSPAREUNIA, INFECTION, BOILS, HIGH ANXIETY, NO SEXUAL RELATIONS, VAGINAL ODOR, SEVERE PAIN, PELVIC PAIN, RECURRENCE OF INCONTINENCE AND VAGINAL BLEEDING. AN EXCISION OF THE MESH WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 65321 | ARIS TRANS-OBTURATOR | PUBOURETHRAL SUPPORT TAPE, PRODUCT CODE: FTL | FTL | COLOPLAST A/S | 5195501000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |