FDA Adverse Event
Injury
Summary report: N
ARIS TRANS-OBTURATOR
MDR report key: 3842735
·
Received January 24, 2014
Report
- Report Number
- 2125050-2014-00098
- Event Type
- Injury
- Date Received
- January 24, 2014
- Date of Event
- August 2, 2013
- Report Date
- January 23, 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, PT WAS IMPLANTED WITH ARIS MESH. LATER THE PT EXPERIENCED VAGINAL AND PELVIC PAIN, FOUL SMELLING VAGINAL DISCHARGE, FELT AS IF A STITCH POPPED, MESH EROSION AND MIGRATION, URINE AND FECAL INCONTINENCE, PALPABLE SUTURE, ABDOMINAL CRAMPING, WORSENING URINARY URGENCY AND FREQUENCY AND DYSPAREUNIA. EXCISIONS OF THE MESH WERE PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 55787 | ARIS TRANS-OBTURATOR | POLYMERIC SURGICAL MESH | FTL | COLOPLAST A/S | 5195512400 | 2789303 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |