BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOLIFE

    MDR report key: 507271 · Received January 6, 2004

    Report

    Report Number
    MW1030829
    Event Type
    Malfunction
    Date Received
    January 6, 2004
    Date of Event
    December 10, 2003
    Report Date
    January 2, 2004
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MIE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON CULTURED TISSUE CRYOPRESERVED AORTIC VALVE PRIOR TO IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOLIFE TISSUE-CRYOPRESERVED AORTIC VALVE MIE CRYOLIFE, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Other