FDA Adverse Event
Injury
Summary report: N
RESTORELLE EZA 6X4 CM
MDR report key: 3501450
·
Received August 29, 2013
Report
- Report Number
- 2125050-2013-00191
- Event Type
- Injury
- Date Received
- August 29, 2013
- Report Date
- August 28, 2013
- Manufacturer
- COLOPLAST A/S
- Product Code
- FTL
- PMA / PMN Number
- K092207
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
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, PT WAS IMPLANTED WITH A RESTORELLE SLING ON (B)(6) 2011. LATER THE PT EXPERIENCED EROSION. MESH CONTRACTION, INFECTION, FISTULA, INFLAMMATION, SCAR TISSUE, ORGAN PERFORATION, DYSPAREUNIA, BLOOD LOSS, NERVE DAMAGE, PAIN, MENTAL AND EMOTIONAL DISTRESS, ANXIETY, PELVIC FLOOR DAMAGE AND HOSPITALIZATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 428083 | RESTORELLE EZA 6X4 CM | SURGICAL MESH | FTL | COLOPLAST A/S | 5013401400 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |