FDA Adverse Event
Injury
Summary report: N
ARIS TRANS-OBTURATOR
MDR report key: 3832070
·
Received February 7, 2014
Report
- Report Number
- 2125050-2014-00174
- Event Type
- Injury
- Date Received
- February 7, 2014
- Date of Event
- May 23, 2011
- Report Date
- February 6, 2011
- 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 THE PT, EXPERIENCED AN UPPER RESPIRATORY INFECTION THAT CAUSED SIGNIFICANT COUGHING AND THE PT FELT A POP, THE LEAKING RETURNED, PAIN, INCONTINENCE, DYSPAREUNIA, MESH EROSION, URETHROVAGINAL FISTULA, SCARRING, SMALL AMOUNT OF ANTERIOR PROLAPSE, SERIOUS PURULENT DRAINAGE, HOLE IN RIGHT LABIAL INCISION WITH SOME NECROSIS OF LATERAL SKIN FLAP AND DEHISCENCE, NUMBNESS AND TENDERNESS AT POINT OF DEBRIDEMENT AND MILE URGE INCONTINENCE. AN EXCISION OF THE MESH WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 79531 | ARIS TRANS-OBTURATOR | POLYMERIC SURGICAL MESH | FTL | COLOPLAST A/S | 5195511400 | 2398095 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |