BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAUN

    MDR report key: 6731439 · Received July 21, 2017

    Report

    Report Number
    1314800-2017-00035
    Event Type
    Malfunction
    Date Received
    July 21, 2017
    Date of Event
    June 12, 2017
    Report Date
    July 21, 2017
    Manufacturer
    KAZ USA, INC., A HELEN OF TROY COMPANY
    Product Code
    FLL
    PMA / PMN Number
    K103800
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING, BUT IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT HER THERMOMETER HAD ALLEGEDLY GIVEN SEVERAL FALSE NEGATIVE READING ON THEIR INFANT SON. THE DEVICE ALLEGEDLY GAVE READINGS THAT WERE 3.2 AND 3.3 DEGREES LOWER THAN THE PATIENTS ACTUAL TEMPERATURE ON TWO SEVERAL OCCASIONS. BOTH TIMES THE CHILD WAS TAKEN TO A HOSPITAL OR WALK IN CLINIC WHERE A FEVER WAS CONFIRMED. IT WAS ALSO ALLEGED THAT THE FALSE NEGATIVE READINGS MAY HAVE CONTRIBUTED TO UNFORESEEN FEBRILE SEIZURES. THERE WERE NO COMPLICATIONS FROM THESE INCIDENTS, AND THE PATIENT IS DOING WELL NOW. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511799 BRAUN EAR THERMOMETER FLL KAZ USA, INC., A HELEN OF TROY COMPANY IRT-6500 37816KTC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R