BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALLOGRAFT HEART VALVE

    MDR report key: 5404450 · Received August 1, 2003

    Report

    Report Number
    3005064037-2003-00001
    Event Type
    Other
    Date Received
    August 1, 2003
    Date of Event
    July 1, 2003
    Report Date
    July 9, 2003
    Manufacturer
    LIFENET HEALTH
    Product Code
    MIE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    1

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLOGRAFT HEART VALVE HUMAN TISSUE HEART VALVE MIE LIFENET HEALTH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Life Threatening| R