BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI APRON

    MDR report key: 105874 · Received July 16, 1997

    Report

    Report Number
    MW1011697
    Event Type
    Malfunction
    Date Received
    July 16, 1997
    Date of Event
    June 16, 1997
    Report Date
    July 16, 1997
    Manufacturer
    EZ-EM, INC.
    Product Code
    EAJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    FOUR LEAD APRONS WERE MFG WITH CONTAMINATED LEAD. THEY HAVE NOT ACTUALLY BEEN TESTED BUT WERE ON LIST OF CATALOG NUMBERS ON RECALL NOTICE FOR THIS PROBLEM. DEVICES HAVE BEEN IN USE SINCE FEB 97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI APRON LEAD APRON EAJ EZ-EM, INC. * NONE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA