FDA Adverse Event
Injury
Summary report: N
RESTORELLE DIRECT FIX POSTERIOR MESH
MDR report key: 5095982
·
Received September 22, 2015
Report
- Report Number
- 2125050-2015-00093
- Event Type
- Injury
- Date Received
- September 22, 2015
- Date of Event
- March 14, 2012
- Report Date
- August 20, 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 DFP MESH. LATER THE PATIENT EXPERIENCED HARD STOOL/CONSTIPATION, SPOTTING, VAGINAL/RECTAL DISCOMFORT, SHORTENED VAGINAL CUFF, SCARRING, RECURRENT SUI, RECTOCELE, DYSPAREUNIA, URGENCY, NOCTURIA, FECAL INCONTINENCE, INCOMPLETE AND PROLONGED VOIDING, PAINFUL DEFECATION, BLADDER NECK MOBILITY, LOW ANAL SPHINCTER PRESSURE AND RECTAL/VAGINAL DESCENT WITH DEFECATION. FIBER THERAPY. A CYSTOURETHROSCOPY WAS PERFORMED AND WAS UNREMARKABLE FOR ABNORMALITIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 625958 | RESTORELLE DIRECT FIX POSTERIOR MESH | SURGICAL MESH | OTP | COLOPLAST CORP | 5012901400 | 10021301 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Other |