BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRAUN

    MDR report key: 2926218 · Received January 16, 2013

    Report

    Report Number
    1314800-2013-00002
    Event Type
    Injury
    Date Received
    January 16, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 11, 2013
    Manufacturer
    KAZ, INC.
    Product Code
    FLL
    PMA / PMN Number
    K031928
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    KAZ USA, INC RECEIVED A REPORT FROM A CONSUMER REGARDING THE USE OF A BRAUN EAR THERMOMETER. SHE ALLEGES THAT USING THE EAR THERMOMETER ON HER DAUGHTERS CAUSED THEM BOTH TO LOSE CONSCIOUSNESS. SHE IS ALSO ALLEGING THAT USE OF THE EAR THERMOMETER CAUSED LEG TREMORS AND A HEART MURMUR IN ONE DAUGHTER. THE CONSUMER TOOK BOTH CHILDREN TO THE HOSPITAL AFTER THE INCIDENT. THERE ARE NO REPORTS OF THE USE OF AN EAR THERMOMETER CAUSING LOSS OF CONSCIOUSNESS OR OTHER MEDICAL PROBLEMS. THE THERMOMETER INVOLVED IN THIS INCIDENT HAS BEEN REQUESTED BACK FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24047 BRAUN THERMOMETER FLL KAZ, INC. IRT-4520 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other