BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADSURE

    MDR report key: 163699 · Received March 27, 1998

    Report

    Report Number
    MW1013565
    Event Type
    Malfunction
    Date Received
    March 27, 1998
    Manufacturer
    ISP TECHNOLOGIES, INC.
    Product Code
    MOT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    1) RADIATION-ONCOLOGY DEPARTMENT TESTS EACH LOT OF RADSURE INDICATORS BEFORE BLOOD BANK PUTS THEM TO USE. 2) THE PROCEDURE INVOLVES IRRADIATING THE INDICATORS USING A 6MV LINEAR ACCELERATOR X-RAY BEAM AT DOSES OF 5,10,15 & 20 GY'S. 3) THE INDICATORS ARE THEN OBSERVED FOR THE APPROPRIATE COLOR CHANGE TO VERIFY THAT THE EXPECTED AMOUNT OF RADIATION HAS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADSURE 25 GY IRRADIATION INDICATOR MOT ISP TECHNOLOGIES, INC. * G57A11U25

    Patients

    Seq Age Sex Outcome Treatment
    1 *