BEUDAMED
    FDA Adverse Event Other Summary report: N

    CRYOVALVE

    MDR report key: 889202 · Received August 20, 2004

    Report

    Report Number
    1063481-2004-00025
    Event Type
    Other
    Date Received
    August 20, 2004
    Date of Event
    July 8, 2004
    Report Date
    August 19, 2004
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MIE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOVALVE HEART VALVE (ALLOCRAFT) MIE CRYOLIFE, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention