FDA Adverse Event
Injury
Summary report: N
RESTORELLE DIRECTFIX POS
MDR report key: 6070325
·
Received November 1, 2016
Report
- Report Number
- 2125050-2016-00338
- Event Type
- Injury
- Date Received
- November 1, 2016
- Date of Event
- September 16, 2011
- Report Date
- November 1, 2016
- Manufacturer
- COLOPLAST A/S
- Product Code
- FTL
- PMA / PMN Number
- K103568
- 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, THE PATIENT'S LEGAL REPRESENTATIVE STATED PAIN, EROSION, EXTRUSION, INFECTION, BLEEDING, URINARY PROBLEMS, BOWEL PROBLEMS, VAGINAL SCARRING, EXCISION AND DYSPAREUNIA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 721453 | RESTORELLE DIRECTFIX POS | SURGICAL MESH | FTL | COLOPLAST A/S | 5014601400 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Other |