BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARTICULATING ARM FOR CEILING MOUNT SYSTEM

    MDR report key: 437328 · Received January 7, 2003

    Report

    Report Number
    437328
    Event Type
    Other
    Date Received
    January 7, 2003
    Date of Event
    December 5, 2002
    Report Date
    December 5, 2002
    Manufacturer
    E-Z-EM, INC.
    Product Code
    FIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CT TECHNICIAN WAS MOVING THE PERCUPUMP INJECTOR FOLLOWING INJECTION AND SCAN. AS THEY MOVED THE CEILING ARTICULATING ARM, THE ARM BROKE OFF COMPLETELY AT IT'S ATTACHMENT SITE TO THE DOWN POST. THE ARTICULATING ARM HIT THE TECHNICIAN ON THE TOP OF THE HEAD AND ON THE SHOULDER. THE INJECTOR WHICH SWUNG DOWN AT THE SAME TIME HIT THEIR LOWER LEG AREA. THEY WERE TAKEN TO THE E.R. AND RELEASED TO HOME, AND HAS BEEN SEEING THEIR DOCTOR FOR FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTICULATING ARM FOR CEILING MOUNT SYSTEM CT INJECTOR ACCESSORY FIH E-Z-EM, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other PERCUPUMP TOUCHSCREEN INJECTOR SYSTEM WITH EDA.