BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALIMED, INC.

    MDR report key: 122313 · Received September 26, 1997

    Report

    Report Number
    122313
    Event Type
    Death
    Date Received
    September 26, 1997
    Date of Event
    July 23, 1997
    Report Date
    July 29, 1997
    Manufacturer
    B.T. MEDICAL
    Product Code
    EAJ
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON 7/10/97 - NOTICE OF ALERT FROM U.S. REGULATORY COMMISSION RE: THE POSSIBILITY OF SHIELDING PRODUCTS CONTAINING LEAD TO BE CONTAMINATED WITH SMALL AMOUNTS OF NATURALLY OCCURRING RADIOACTIVE MATERIAL. THE HOSP. TESTED TWO APRONS AND FOUND THEM TO HAVE LOW LEVEL RADIATION CONTAMINATION. THE APRONS WERE RETURNED TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALIMED, INC. LEAD APRONS (2) EAJ B.T. MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death