BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORELLE DIRECTFIX POS

    MDR report key: 6072995 · Received November 2, 2016

    Report

    Report Number
    2125050-2016-00342
    Event Type
    Injury
    Date Received
    November 2, 2016
    Report Date
    November 2, 2016
    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.

    Description of Event or Problem · 1

    AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT'S LEGAL REPRESENTATIVE STATED UTI, SUI, URGE INCONTINENCE, RECURRENT RECTOCELE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724668 RESTORELLE DIRECTFIX POS SURGICAL MESH FTL COLOPLAST A/S 5014601400

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other