FDA Adverse Event
Injury
Summary report: N
ARIS TRANS-OBTURATOR
MDR report key: 3842804
·
Received January 24, 2014
Report
- Report Number
- 2125050-2014-00114
- Event Type
- Injury
- Date Received
- January 24, 2014
- Date of Event
- May 21, 2009
- Report Date
- January 23, 2014
- Manufacturer
- COLOPLAST MANUFACTURING US, LLC
- 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 ABDOMINAL AND PELVIC PAIN, DIFFICULTY WITH URINATION AND A URINARY TRACT INFECTION. A REMOVAL OF THE MESH WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 55891 | ARIS TRANS-OBTURATOR | POLYMERIC SURGICAL MESH | FTL | COLOPLAST MANUFACTURING US, LLC | 5195511400 | 1731169 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |