BEUDAMED
    FDA Adverse Event Other Summary report: N

    AORTIC ALLOGRAFT

    MDR report key: 509448 · Received December 4, 2003

    Report

    Report Number
    1060698-2003-00001
    Event Type
    Other
    Date Received
    December 4, 2003
    Date of Event
    November 17, 2003
    Report Date
    November 21, 2003
    Manufacturer
    ALABAMA TISSUE CENTER, INC.
    Product Code
    MIE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AORTIC ALLOGRAFT VALVE MIE ALABAMA TISSUE CENTER, INC. NA 2602086

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization