BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOBILE SHIELD

    MDR report key: 125210 · Received October 8, 1997

    Report

    Report Number
    MW1012251
    Event Type
    Malfunction
    Date Received
    October 8, 1997
    Date of Event
    October 7, 1997
    Report Date
    October 8, 1997
    Manufacturer
    BAR-RAY PRODUCTS, INC.
    Product Code
    IWQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER TESTED THE PRODUCT WITH THE PANCAKE PROBE (GEIGER COUNTER) AND FOUND IT TO BE CONTAMINATED AS EVIDENCED BY A READING OF .5 MR/HR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOBILE SHIELD * IWQ BAR-RAY PRODUCTS, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA