BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRAL SIZER HANDLE

    MDR report key: 1232285 · Received November 5, 2008

    Report

    Report Number
    6000002-2008-09182
    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

    REPORTEDLY, ITEM RETURNED FROM FOOTHILLS HOSP PER PHONE CONVERSATION WITH COMPANY REP. NO PT INFO, HANDLE RETURNED CRACKED OR MISSING PIECES. UNK IF BEFORE OR DURING USE.

    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