BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARIS/COLOPLAST

    MDR report key: 1288106 · Received January 13, 2009

    Report

    Report Number
    MW5009615
    Event Type
    Injury
    Date Received
    January 13, 2009
    Date of Event
    November 21, 2008
    Report Date
    January 13, 2009
    Manufacturer
    ARIS/COLOPLAST
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD TO HAVE SURGICAL MESH REMOVED. DATES OF USE: 2008. DIAGNOSIS: PROLAPSED BLADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARIS/COLOPLAST SURGICAL MESH FTL ARIS/COLOPLAST 93-4400 1672685

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization