FDA Adverse Event
Injury
Summary report: N
RESTORELLE DIRECTFIX POSTERIOR
MDR report key: 4210448
·
Received October 29, 2014
Report
- Report Number
- 2125050-2014-00420
- Event Type
- Injury
- Date Received
- October 29, 2014
- Date of Event
- October 7, 2013
- Report Date
- October 29, 2014
- Manufacturer
- COLOPLAST A/S
- Product Code
- FTL
- 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 NOT RETURNED.
Description of Event or Problem · 1
AS REPORTED TO COLOPLAST THOUGH NOT VERIFIED, PATIENT WAS IMPLANTED WITH RESTORELLE DIRECTFIX POSTERIOR MESH. LATER THE PATIENT EXPERIENCED CONSTIPATION, URINARY LEAKAGE, PELVIC PRESSURE, PAIN, CYSTOCELE, URINARY URGENCY, TENDER UNDER URETHRA, TIGHT TAPE, DYSFUNCTIONAL VOIDING, BLADDER DISCOMFORT AND PRESSURE. MIRALAX, DUCOLAX, ENABLEX WERE PRESCRIBED. AN EXCISION OF THE MESH WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 692502 | RESTORELLE DIRECTFIX POSTERIOR | SURGICAL MESH | FTL | COLOPLAST A/S | 5014602400 | 2967400 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Hospitalization| O |