FDA Adverse Event
Injury
Summary report: N
RESTORELLE EZP
MDR report key: 3636390
·
Received November 1, 2013
Report
- Report Number
- 2125050-2013-00463
- Event Type
- Injury
- Date Received
- November 1, 2013
- Date of Event
- July 20, 2010
- Report Date
- November 4, 2013
- 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 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, PATIENT WAS IMPLANTED WITH RESTORELLE EZP MESH. LATER THE PATIENT EXPERIENCED A BASEBALL SIZE HEMATOMA THAT HAD FORMED IN THE RETROVAGINAL SPACE THE SAME DAY AS THE IMPLANT, DIFFUSE OOZING WAS OBSERVED. THE MESH WAS CUT BUT NOT ENTIRELY REMOVED IN ORDER TO COMPLETE THE HEMATOMA EVACUATION. THE PATIENT REPORTED A BULGE IN THE VAGINAL AREA THREE MONTHS POSTOPERATIVELY, DYSPAREUNIA AND POSTERIOR PROLAPSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 565046 | RESTORELLE EZP | SURGICAL MESH | FTL | COLOPLAST A/S | 5013501400 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |