BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4173505

    MDR report key: 301502 · Received October 25, 2000

    Report

    Report Number
    1718873-2000-00013
    Event Type
    Injury
    Date Received
    October 25, 2000
    Date of Event
    September 19, 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, STAPHYLOCOCCUS AUREUS WITH THROMBOCYTOPENIA. UMBILICAL ARTERY CATHETER REMOVED. CHEST CT SHOWED 1.4 X 1.4 CM DILATION AT THE DESCENDING AORTA JUST DISTAL TO THE AORTIC ARCH; NOTED THROMBUS LOCATED IN THE LEFT LATERAL ASPECT OF ANEURYSM. PT 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 16 DAY Life Threatening| O