BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOLOGY FILMS

    MDR report key: 559503 · Received November 15, 2004

    Report

    Report Number
    MW1033793
    Event Type
    Malfunction
    Date Received
    November 15, 2004
    Date of Event
    July 12, 2004
    Report Date
    November 15, 2004
    Manufacturer
    *
    Product Code
    IWZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CONCERN HAS BEEN RAISED THAT THE FONT OF THE PT IDENTIFICATION AND INFO SECTION ON RADIOLOGY FILMS IS SMALL AND SOMETIMES DIFFICULT TO READ. THERE IS A LOT OF INFO WHICH IS TO BE PLACED IN THIS AREA AND THE SIZE OF THIS INFO BOX IS UNIFORM WITHIN THE RADIOLOGY FILM MFG INDUSTRY. SMALLER FONTS ARE THEREFORE USED TO ENABLE THE INCLUSION OF ALL REQUIRED INFO, WHICH IN TURN MAKES IT DIFFICULT TO READ THE INFO AND DIFFICULT TO VERIFY PT INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIOLOGY FILMS * IWZ * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other