BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALVE AORTIC MAGNA TFX 25MM

    MDR report key: 1963748 · Received January 12, 2011

    Report

    Report Number
    MW5019002
    Event Type
    Injury
    Date Received
    January 12, 2011
    Date of Event
    November 29, 2010
    Report Date
    January 12, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD "REDO AORTIC VALVE REPLACEMENT" ON (B)(6) 2010. PT WAS READMITTED ON (B)(4) 2010 WITH ENDOCARDITIS AND VEGETATIONS ON AORTIC VALVE. BLOOD CULTURES GREW (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALVE AORTIC MAGNA TFX 25MM AORTIC VALVE DYE EDWARDS LIFESCIENCES 2441065

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| S