BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORELLE

    MDR report key: 5076166 · Received September 14, 2015

    Report

    Report Number
    2125050-2015-00089
    Event Type
    Injury
    Date Received
    September 14, 2015
    Date of Event
    March 22, 2013
    Report Date
    June 8, 2015
    Manufacturer
    COLOPLAST CORP
    Product Code
    OTO
    PMA / PMN Number
    K132061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING DUPLICATED AND RE-SUBMITTED PER REQUEST FROM FDA. COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT. DEVICE WAS NOT RETURNED. EXEMPTION NUMBER E2014015. TOTAL NUMBER OF EVENTS REPORTED: 51. 8 - NOVASILK. 43 - RESTORELLE.

    Description of Event or Problem · 1

    AS REPORTED TO COLOPLAST THOUGH NOT VERIFIED, PATIENT WAS IMPLANTED WITH RESTORELLE MESH. LATER THE PATIENT EXPERIENCED DYSPAREUNIA AND MESH EROSION. A MESH EXCISION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608091 RESTORELLE SURGICAL MESH OTO COLOPLAST CORP 11041101

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention| O