FDA Adverse Event
Injury
Summary report: N
RESTORELLE DIRECTFIX POS
MDR report key: 3939194
·
Received June 18, 2014
Report
- Report Number
- 2125050-2014-00377
- Event Type
- Injury
- Date Received
- June 18, 2014
- Date of Event
- May 15, 2012
- Report Date
- June 17, 2014
- Manufacturer
- COLOPLAST A/S
- Product Code
- FTL
- PMA / PMN Number
- K103568
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
COLOPLAST HAS NOT BEEN 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 DIRECTFIX POS MESH. LATER THE PATIENT EXPERIENCED VAGINAL BLEEDING, MESH EXPOSURE, URINARY URGENCY AND FREQUENCY. ESTRACE WAS PRESCRIBED, AN EXCISION OF THE EXPOSED MESH WAS PERFORMED AND INTERSTIM AND PERIPHERAL NERVE EVALUATION (PNE) LEAD PLACEMENTS WERE PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 356826 | RESTORELLE DIRECTFIX POS | SURGICAL MESH | FTL | COLOPLAST A/S | 5014601400 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |