FDA Adverse Event
Injury
Summary report: N
RESTORELLE DIRECT FIX POSTERIOR MESH
MDR report key: 5025554
·
Received August 24, 2015
Report
- Report Number
- 2125050-2015-00085
- Event Type
- Injury
- Date Received
- August 24, 2015
- Date of Event
- January 2, 2013
- Report Date
- July 24, 2015
- Manufacturer
- COLOPLAST CORP
- Product Code
- OTP
- 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. DEVICE WAS NOT EXPLANTED OR RETURNED.
Description of Event or Problem · 1
AS REPORTED TO COLOPLAST THOUGH NOT VERIFIED, PATIENT WAS IMPLANTED WITH RESTORELLE DIRECT FIX POSTERIOR MESH. LATER THE PATIENT EXPERIENCED EXPOSED MESH ON THE RIGHT SIDE UNDER HER URETHRA; RECURRENT RECTOCELE AND SIGNIFICANT SCAR ALONG POSTERIOR WALL; RESTORELLE MESH WAS NOT ATTACHED WELL LATERALLY OR DISTALLY AND WAS WRINKLED. A PARTIAL EXPLANT WAS PERFORMED; EXCISION OF RESTORELLE VAGINAL MESH POSTERIORLY WAS PERFORMED WITH A RECTOCELE REPAIR AND CYSTOSCOPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 559210 | RESTORELLE DIRECT FIX POSTERIOR MESH | SURGICAL MESH | OTP | COLOPLAST CORP | 5012901400 | 10040601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Other| R |