BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 113932 · Received August 18, 1997

    Report

    Report Number
    MW1011906
    Event Type
    Malfunction
    Date Received
    August 18, 1997
    Date of Event
    August 12, 1997
    Report Date
    August 14, 1997
    Manufacturer
    UNK
    Product Code
    EAJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INDEPENDENT FIRM CONDUCTED A CONTAMINATION SURVEY OF ALL LEAD APRONS AND OTHER SHIELDING DEVICES IN DEPT. THIS SURVEY WAS PROMPTED BY THE NEWS THAT SOME RECENTLY PURCHASED LEAD SHIELDING PRODUCTS CONTAINED SMALL AMOUNTS OF NATURALLY OCCURRING RADIONUCLIDES; NAMELY 210 LEAD AND DAUGHTERS 210 BISMUTH AND 210 POLONIUM. THE PRIMARY RADIATION TO BE MEASURED IS A 1.6 MEV BETA PARTICLE FROM 210 BISMUTH FOLLOWED BY K-SHELL XRAYS OF 88 KEV OR LESS. INTERNET REPORTS HAVE PLACED THE EXPOSURE LEVELS AT 0.2-3 MR/HR BASED UPON DEGREE OF CONTAMINATION. THE BETA PARTICLE PENETRATION RANGE IS VERY SHORT AND WILL CONTRIBUTE LITTLE TO THE DEEP DOSE RECEIVED BY THE WEARER. DOSE WILL ARISE MAINLY FROM THE 88 KEV XRAYS. WITH THIS KNOWLEDGE, FIRM CONDUCTED A SURVEY OF ALL LEAD APRONS AND THYROID SHIELDS IN DEPT USING A LUDLUM MODEL 3 GM SURVEY METER ATTACHED TO A LUDLUM MODEL 44-3 LOW ENERGY XRAY SCINTILLATION PROBE. THE EFFICIENCY OF THIS PROBE WAS DETERMINED TO BE 14.4% WHEN THIS INSTRUMENT WAS CALIBRATED ON JUNE 27, 1997. IF CONTAMINATION WAS FOUND, THE ACTUAL CONTACT EXPOSURE WAS DETERMINED USING A RECENTLY CALIBRATED VICTOREEN MODEL 450 ION CHAMBER WITH BETA CAP REMOVED. OF THE 42 LEAD APRONS AND ASSOCIATED THYROID SHIELDS SURVEYED, THERE WERE TWO APRONS THAT DEMONSTRATED CONTAMINATION. BOTH WERE MFG DURING MAY, 1997. THE FIRST WAS A POLKA DOT WRAP AROUND (W/A) APRON WHICH DEMONSTRATED 1000 NET CPM (6944 DPM) AND AN EXPOSURE RATE OF 0.18 MR/HR AT CONTACT ON TWO FRONT WRAP AROUND PANELS. THERE WAS NO CONTAMINATION DEMONSTRATED IN THE BACK PANEL OF THE APRON. THE SECOND APRON WAS A DARK GREEN VEST/SKIRT COMBINATION. THE VEST AND SKIRT BOTH DEMONSTRATED 1250 NET CPM (8681 DPM) AND AN EXPOSURE RATE OF 0.3 MR/HR AT CONTACT. THE VEST BACK PANEL AND ALL THREE PANELS OF THE SKIRT EXHIBITED CONTAMINATION. COMMENTS: #1 MEASURED 1000 NET CPM; 0.18 MR/HR ON TWO FRONT WRAP AROUND PANELS; NO COUNTS ON BACK PANEL. #2 MEASURED 1250 NET CPM; 0.3 MR/HR ON VEST BACK PANEL; 0.3 MR/HR ON ALL THREE PANELS OF SKIRT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK LEAD APRON EAJ UNK * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *