BEUDAMED
    FDA Adverse Event Death Summary report: N

    GESCO

    MDR report key: 298062 · Received September 29, 2000

    Report

    Report Number
    MW1020032
    Event Type
    Death
    Date Received
    September 29, 2000
    Date of Event
    July 12, 2000
    Report Date
    September 27, 2000
    Manufacturer
    UTAH MEDICAL PRODUCTS, INC.
    Product Code
    FOS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INFANT DEVELOPED SEPSIS, KLEBSIELLA PNEUMONIAE AND ENTEROCOCCUS FAECALIS 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 A 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 GESCO 3.5 UMBILICAL CATHETER/UMBILI-CATH FOS UTAH MEDICAL PRODUCTS, INC. UMBILI-CATH 3.5 FR *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 DAY Death| O