BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREATHALYZER

    MDR report key: 910392 · Received September 10, 2007

    Report

    Report Number
    MW5003708
    Event Type
    Injury
    Date Received
    September 10, 2007
    Date of Event
    July 1, 2007
    Report Date
    September 7, 2007
    Product Code
    DJZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US

    Narratives

    Description of Event or Problem · 1

    IN 2007, I WAS ASKED TO GIVE A BREATHALYZER SAMPLE AT THE CRIMINAL PROCESS CENTER. I OBSERVED CONDENSATION INSIDE THE CLEAR TUBE LEADING FROM THE MOUTH PIECE INTO THE TEST DEVICE. THIS CONDENSATION OBVIOUSLY COLLECTED IN THE TUBE FROM PREVIOUS TEST SUBJECTS. I AM REQUIRED BY LAW TO GIVE A SAMPLE OF MY BREATH OR LOSE MY DRIVING PRIVILEGES FOR A YEAR. I COULD NOT GIVE A SAMPLE IN GEAR OF ACCIDENTALLY INHALING ANY AIRBORNE OR FOREIGN GERMS. THIS IS NOT A PROPER SANITARY PRACTICE AND I HAVE BEEN GETTING THE RUN AROUND FROM LOCAL SOURCES. YOU ARE, I UNDERSTAND, RESPONSIBLE FOR INSURING THE DEVICES I HAVE DESCRIBED EARLIER ARE BEING KEPT TO FDA STANDARDS. PLEASE HAVE ONE OF YOUR REPRESENTATIVES CALL ME AS SOON AS POSSIBLE OR CALL MY LEGAL REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREATHALYZER DJZ UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening| O