BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD APRON

    MDR report key: 103398 · Received July 8, 1997

    Report

    Report Number
    MW1011644
    Event Type
    Malfunction
    Date Received
    July 8, 1997
    Date of Event
    June 27, 1997
    Report Date
    July 8, 1997
    Manufacturer
    BURLINGTON MEDICAL SUPPLIES
    Product Code
    EAJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    FACILITY RECEIVED FDA NOTICE ON CONTAMINATED LEAD APRONS AND ISOLATED THE APRON AND THE TWO THYROID SHIELDS PURCHASED DURING THIS TIME. THE LEAD APRON AND THE TWO THYROID SHIELDS WERE TAKEN TO THE NUCLEAR MEDICINE DEPARTMENT. THEY SCANNED THEM USING THIN WINDOW MEI 50 GM METER AND FOUND THE READINGS TO BE .04, THE BACKGROUND BEING .01. FACILITY CALLED THE MANAGER AT BURLINGTON MEDICAL SUPPLIES INCORP. AND HE TOLD THEM THAT THEY WOULD REPLACE THE APRON AND THE TWO THYROID SHIELDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD APRON THYROID SHIELDS EAJ BURLINGTON MEDICAL SUPPLIES UNK UNK
    2 LEAD APRON THYROID SHIELDS KPY BURLINGTON MEDICAL SUPPLIES UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA