BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 1714062 · Received June 3, 2010

    Report

    Report Number
    1714062
    Event Type
    Malfunction
    Date Received
    June 3, 2010
    Date of Event
    April 5, 2010
    Report Date
    June 3, 2010
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    DYE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RE-DO AORTIC VALVE REPLACEMENT FOR SIGNIFICANT PROSTHETIC VALVE DEGENERATION. AORTIC VALVE IMPLANTED SIX YEARS AGO. PATIENT EVALUATED BY AN ECHOCARDIOGRAM, WHICH REVEALED A MODERATELY SEVERE PROSTHETIC VALVE AORTIC INCOMPETENCE WITH MODERATE MITRAL AND TRICUSPID REGURGITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK REPLACEMENT HEART-VALVE DYE EDWARDS LIFESCIENCES LLC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR