FDA Adverse Event
Injury
Summary report: N
ARIS TRANS-OBTURATOR
MDR report key: 3842829
·
Received August 21, 2013
Report
- Report Number
- 2125050-2013-00186
- Event Type
- Injury
- Date Received
- August 21, 2013
- Date of Event
- August 9, 2012
- Report Date
- August 21, 2013
- 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 EXPERIENCED EROSION, AN ULTRASOUND DUE TO PELVIC PAIN AND STRESS URINARY INCONTINENCE. A SLING REMOVAL WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 407048 | ARIS TRANS-OBTURATOR | POLYMERIC SURGICAL MESH | FTL | COLOPLAST A/S | 5195102400 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |