BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIMOUNT MAGNA EASE AORTIC SIZER

    MDR report key: 1232299 · Received November 5, 2008

    Report

    Report Number
    6000002-2008-09198
    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

    CONCLUSIONS: DEVICE EVALUATION ANTICIPATED, BUT NOT BEGUN.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERIMOUNT MAGNA EASE AORTIC SIZER REPLACEMENT HEART VALVE SIZER DTI EDWARDS LIFESCIENCES 1133 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK