BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 501968 · Received December 15, 2003

    Report

    Report Number
    MW1030574
    Event Type
    Malfunction
    Date Received
    December 15, 2003
    Date of Event
    November 8, 2003
    Report Date
    December 3, 2003
    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 AORTIC VALVE & CONDUIT IN O.R. BEFORE TRANSPLANTING IT INTO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * AORTIC VALVE & CONDUIT MIE CRYOLIFE, INC. * 1114,006

    Patients

    Seq Age Sex Outcome Treatment
    1 19 MO
    2