BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAMP

    MDR report key: 2151705 · Received June 27, 2011

    Report

    Report Number
    2151705
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 27, 2011
    Manufacturer
    MCROBERTS SECURITY TECHNOLOGIES
    Product Code
    HFW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    CORD CLAMPS USED TO SECURE INFANT LOCATOR SENSORS CUT THROUGH ONE OF THE UMBILICAL VESSELS. THERE IS A RIGHT ANGLE ON THE CLAMP; IF THE CORD IS THICK, IT MIGHT GET CAUGHT AND CAUSE EXSANGUINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLAMP UMBILICAL CLAMP HFW MCROBERTS SECURITY TECHNOLOGIES CLAMP-001 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *