BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRAL SIZER HANDLE

    MDR report key: 1232283 · Received November 5, 2008

    Report

    Report Number
    6000002-2008-09179
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 15, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DTI
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL ANTICIPATED BUT NOT BEGUN.

    Description of Event or Problem · 1

    PT INFO IS UNK. IT WAS REPORTED THAT THE SIZER HANDLE CRACKED DURING USE. THE REPORTED MODEL IS A 1117, THE SPECIFIC SIZE OR SIZES INVOLVED WERE NOT REPORTED. DEVICE IS BEING RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITRAL SIZER HANDLE REPLACEMENT HEART VALVE HANDLE DTI EDWARDS LIFESCIENCES 1117 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK