FDA Adverse Event
Injury
Summary report: N
SUPRIS SUPRAPUBIC
MDR report key: 3840758
·
Received January 30, 2014
Report
- Report Number
- 2125050-2014-00133
- Event Type
- Injury
- Date Received
- January 30, 2014
- Date of Event
- March 22, 2012
- Report Date
- January 30, 2014
- Manufacturer
- COLOPLAST A/S
- Product Code
- OTN
- PMA / PMN Number
- K111233
- 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 SUPRIS SUPRAPUBIC AND EXAIR MESH. LATER THE PT EXPERIENCED MESH EROSION AND MIGRATION, INFECTION DYSPAREUNIA, BLEEDING, PAIN AND VAGINAL SCARRING. AN EXCISION AND REMOVAL OF THE MESH WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 65874 | SUPRIS SUPRAPUBIC | SURGICAL MESH, PRODUCT CODE: OTN | OTN | COLOPLAST A/S | 5195611400 | 2228486 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |