BEUDAMED
    FDA Adverse Event Other Summary report: N

    CRD-201

    MDR report key: 513023 · Received February 25, 2004

    Report

    Report Number
    1718873-2004-00001
    Event Type
    Other
    Date Received
    February 25, 2004
    Date of Event
    February 6, 2004
    Report Date
    February 20, 2004
    Manufacturer
    UTAH MEDICAL PRODUCTS, INC.
    Product Code
    HFW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE CORDGUARD WAS USED DURING A DIFFICULT C-SECTION, INSULIN DEPENDENT DIABETIC MOTHER, WITH A LARGE BABY. AFTER THE UMBILICAL CORD WAS CUT AND THE INFANT WAS MOVED FROM THE FIELD THE CLAMP CAME OFF. THE INFANT LOST AN UNDETERMINED AMOUNT OF BLOOD. BOTH THE MOTHER AND THE BABY ARE DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRD-201 CORDGUARD II HFW UTAH MEDICAL PRODUCTS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention