FDA Adverse Event
Injury
Summary report: N
ARIS TRANS - OBTURATOR
MDR report key: 3842736
·
Received January 24, 2014
Report
- Report Number
- 2125050-2014-00100
- Event Type
- Injury
- Date Received
- January 24, 2014
- Date of Event
- March 17, 2010
- 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 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 LOWER BACK PAIN, SCIATICA, DYSPAREUNIA, BLEEDING, MESH EROSION AND STRESS INCONTINENCE. AN EXCISION OF MESH AND CYSTOSCOPY WERE PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 55883 | ARIS TRANS - OBTURATOR | POLYMERIC SURGICAL MESH | FTL | COLOPLAST A/S | 2185511400 | 1858783 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |