BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GERMATHERM

    MDR report key: 5274062 · Received December 4, 2015

    Report

    Report Number
    MW5058368
    Event Type
    Injury
    Date Received
    December 4, 2015
    Date of Event
    November 29, 2015
    Report Date
    December 4, 2015
    Manufacturer
    R.G. MEDICAL DIAGNOSTICS
    Product Code
    FLK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER STATES THAT, SHE PLACED A THERMOMETER IN HER CHILD'S MOUTH AND THE TIP BROKE INSIDE HIS MOUTH. HOWEVER, SHE WAS ABLE TO RETRIEVE THE BROKEN PIECE BY ASKING THE CHILD TO SPIT IT OUT. SHE IS CONCERNED WITH THE MATERIAL INTEGRITY OF THE PRODUCT (THERMOMETER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796779 GERMATHERM THERMOMETER FLK R.G. MEDICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR