BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GERMATHERM

    MDR report key: 1520660 · Received November 1, 2009

    Report

    Report Number
    MW5013300
    Event Type
    Injury
    Date Received
    November 1, 2009
    Date of Event
    October 12, 2009
    Report Date
    November 1, 2009
    Manufacturer
    R.G. MEDICAL DIAGNOSTICS
    Product Code
    FLL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    OUR SON, USED A THERMOMETER UNDER HIS MOTHER'S SUPERVISION. THE THERMOMETER BROKE IN HIS MOUTH, CUTTING HIS GUMS, AND FILLING HIS MOUTH WITH THE BLACK LIQUID THAT WAS INSIDE THE THERMOMETER. THE LIQUID WAS SWALLOWED SOMEWHAT BY PT, HOW MUCH WE DO NOT KNOW. THE GLASS BROKE IN MANY PIECES IN HIS MOUTH, WE DO NOT KNOW HOW MUCH, IF ANY, GLASS WAS SWALLOWED. HE SPIT OUT THE LIQUID ONTO OUR CARPET, STAINING IT TO WHERE WE CANNOT GET ALL OF IT OUT. PT DID NOT BITE DOWN HARD ON THE THERMOMETER, JUST HELD IT UNDER HIS TONGUE NORMALLY. HE DID NOT USE EXCESSIVE PRESSURE. THE THERMOMETER IS A GERMATHERM, MERCURY FREE ORAL THERMOMETER. IT SAYS THAT IT IS FDA LISTED, MADE IN A FOREIGN COUNTRY. I CONTACTED THE COMPANY LAST WEEK TO REPORT THIS PROBLEM, AND HAVE NOT HEARD BACK FROM THEM AS OF YET. DATES OF USE: 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GERMATHERM THERMOMETER FLL R.G. MEDICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Other