FDA Adverse Event
Injury
Summary report: N
ARIS TRANS-OBUTRATOR
MDR report key: 3832037
·
Received February 7, 2014
Report
- Report Number
- 2125050-2014-00190
- Event Type
- Injury
- Date Received
- February 7, 2014
- Date of Event
- April 4, 2012
- Report Date
- February 6, 2014
- Manufacturer
- COLOPLAST A/S
- Product Code
- FTL
- PMA / PMN Number
- K050148
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- 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 PT EXPERIENCED PELVIC PAIN, DISCOMFORT WITH PROLONGED SITTING, PAIN BETWEEN THE URETHRA AND VAGINA, MIXED INCONTINENCE, URINARY TRACT INFECTION, ABDOMINAL PAIN AND FREQUENCY. AN EXCISION OF THE MESH WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 79191 | ARIS TRANS-OBUTRATOR | PUBORUETHRAL SUPPORT TAPE | FTL | COLOPLAST A/S | 5195501000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |