FDA Adverse Event
Injury
Summary report: N
RESTORELLE DIRECTFIX ANTERIOR
MDR report key: 3832127
·
Received February 7, 2014
Report
- Report Number
- 2125050-2014-00159
- Event Type
- Injury
- Date Received
- February 7, 2014
- Date of Event
- December 10, 2011
- Report Date
- February 6, 2014
- Manufacturer
- COLOPLAST A/S
- 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 DIRECTFIX MESH. LATER THE PT EXPERIENCED RECURRENT COMPLETE PROLAPSE, RECURRENCE OF BLADDER PROLAPSE, ANEMIA AND PAIN. A REMOVAL OF THE RESTORELLE MESH WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 80034 | RESTORELLE DIRECTFIX ANTERIOR | SURGICAL MESH | FTL | COLOPLAST A/S | 5014501400 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |