BEUDAMED
    FDA Adverse Event Death Summary report: N

    4173505

    MDR report key: 301396 · Received October 25, 2000

    Report

    Report Number
    1718873-2000-00012
    Event Type
    Death
    Date Received
    October 25, 2000
    Date of Event
    July 12, 2000
    Report Date
    October 23, 2000
    Manufacturer
    UTAH MEDICAL PRODUCTS, INC.
    Product Code
    FOS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INFANT DEVELOPED SEPSIS, KLEBSIELLA PNEUMONIAE AND ENTEROCOCCUS FAECALLS AT 16 DAYS OF AGE WITH THROMBOCYTOPENIA. AT 21 DAYS OF AGE, UMBILICAL ARTERIAL CATHETER WAS REMOVED. ABDOMINAL ULTRASOUND AT 58 DAYS OF AGE SHOWED 3.5 X 3.5 CM VASCULAR MASS, MID ABDOMEN BETWEEN THE DIAPHRAGM AND RENAL VESSELS WITH BLOOD FLOW CLEARLY WITHIN THE MASS. ANEURYSM CONFIRMED BY CARDIOLOGIST AND INFANT TRANSFERRED FOR LIFE THREATENING SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4173505 UMBILICAL CATHETER, SILICON, 3.5 FRENCH, SL FOS UTAH MEDICAL PRODUCTS, INC. NA NOT AVAIL

    Patients

    Seq Age Sex Outcome Treatment
    1 59 DAY Death