FDA Adverse Event
Injury
Summary report: N
RESTORELLE DIRECT FIX POSTERIOR
MDR report key: 2831689
·
Received November 14, 2012
Report
- Report Number
- 2125050-2012-00110
- Event Type
- Injury
- Date Received
- November 14, 2012
- Report Date
- November 14, 2012
- Manufacturer
- COLOPLAST A/S
- Product Code
- FTL
- PMA / PMN Number
- K103568
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THIS REPORT. (B)(4): DEVCIE NOT RETURNED.
Description of Event or Problem · 1
PATIENT IMPLANTED WITH RESTORELLE AND COMPETITORS PRODUCT. LATER PATIENT EXPERIENCED PERSONAL INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORELLE DIRECT FIX POSTERIOR | SURGICAL MESH | FTL | COLOPLAST A/S | 5014601400 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |