BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTIVE GARMENT

    MDR report key: 110590 · Received July 29, 1997

    Report

    Report Number
    110590
    Event Type
    Malfunction
    Date Received
    July 29, 1997
    Report Date
    July 21, 1997
    Manufacturer
    EZ-EM, INC.
    Product Code
    EAJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    MFR (EZ-EM, INC.) INFORMED HOSP THAT LEAD USED IN FABRICATION OF APRONS AND OTHER PROTECTIVE GARMENTS BETWEEN 2/1/97 AND 5/31/97 CONTAIN SMALL AMOUNTS OF RADIOACTIVE SUBSTANCE (RADIOACTIVE CONTAMINATION)-THESE PATENT-CONTAMINATED APRONS WERE IDENTIFIED AND CHECKED FOR RADIOACTIVITY. FIVE APRONS AND EIGHT THYROID SHIELDS WERE FOUND CONTAMINATED, REMOVED FROM SERVICE. MFR CONTACTED FOR PICK-UP. RADIATION EXPOSURE/DOSE TO PERSONNEL WHOE WORE ITEMS ESTIMATED IS LESS THAN 0.5% OF ANNUAL OCC. DOSE LIMITS (EQUIV. TO 2-3 CHEST X-RAYS). NO HEALTH HAZARD ASSOCIATED TO THIS AMOUNT OF RADIATION EXPOSURE. NOTE: PICKER RECALLED ITEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTECTIVE GARMENT APRONS AND THYROID SHIELDS EAJ EZ-EM, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other