BEUDAMED
    FDA Adverse Event Death Summary report: N

    CRYOLIFE

    MDR report key: 415436 · Received September 6, 2002

    Report

    Report Number
    415436
    Event Type
    Death
    Date Received
    September 6, 2002
    Date of Event
    July 23, 2002
    Report Date
    September 5, 2002
    Manufacturer
    CRYOLIFE INC.
    Product Code
    LMO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    S/P CRYOLIFE ALLOGRAFT FEMORAL VEIN IMPLANT. PT DEVELOPED INFECTION NOT NORMALLY ACQUIRED THROUGH OTHER EXPOSURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOLIFE ALOGRAFT FEMORAL VEING LMO CRYOLIFE INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death| H