BEUDAMED
    FDA Adverse Event Other Summary report: N

    CRYOLIFE, INC.

    MDR report key: 417158 · Received September 13, 2002

    Report

    Report Number
    MW1026184
    Event Type
    Other
    Date Received
    September 13, 2002
    Date of Event
    July 24, 2002
    Report Date
    September 13, 2002
    Manufacturer
    *
    Product Code
    LMO
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD CRYOGRAFT PLACEMENT. THEY WERE READMITTED X 3 SINCE THE PLACEMENT AND FEELS THEIR CURRENT BACTEREMIA MAY BE RELATED TO AN INFECTED CRYOGRAFT PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOLIFE, INC. FEMORAL VEIN - CADAVERIC 9MM-12MM X 38CM LMO * SEE ATTACHED *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other