FDA Adverse Event
Injury
Summary report: N
RESTORELLE M RECT
MDR report key: 3832075
·
Received February 7, 2014
Report
- Report Number
- 2125050-2014-00167
- Event Type
- Injury
- Date Received
- February 7, 2014
- Date of Event
- December 30, 2010
- Report Date
- February 6, 2014
- Manufacturer
- COLOPLAST A/SS
- Product Code
- FTL
- PMA / PMN Number
- K092207
- 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 RESTORELLE MESH. LATER THE PT EXPERIENCED URINARY RETENTION, MESH EROSION, INFECTION, PAIN, SCARRING AND BLEEDING. AN EXCISION OF THE MESH WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 79286 | RESTORELLE M RECT | SURGICAL MESH | FTL | COLOPLAST A/SS | 5013201400 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |