BEUDAMED
    FDA Adverse Event Death Summary report: N

    *

    MDR report key: 1041332 · Received May 2, 2008

    Report

    Report Number
    8030638-2008-00005
    Event Type
    Death
    Date Received
    May 2, 2008
    Manufacturer
    GAMBRO RENAL PRODUCTS S.A. DE C.V.
    Product Code
    FJK
    PMA / PMN Number
    k070414
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE BLOOD TUBING SET FROM THIS INCIDENT WAS DISCARDED AND UNAVAILABLE FOR INSPECTION. RETAINED SAMPLES FROM THE SAME LOT NUMBER 03P158227 WERE VISUALLY INSPECTED, FUNCTIONAL TESTING PERFORMED WITH NO FAILURES DETECTED. ADD'L INFO WILL BE PROVIDED WHEN IT COMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * FJK GAMBRO RENAL PRODUCTS S.A. DE C.V. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *