BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRAUN

    MDR report key: 3780969 · Received April 23, 2014

    Report

    Report Number
    1314800-2014-00037
    Event Type
    Other
    Date Received
    April 23, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    KAZ, INC.
    Product Code
    FLL
    PMA / PMN Number
    K031928
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT HER THERMOMETER HAD ALLEGEDLY GIVEN A FALSE NEGATIVE READING. THE DEVICE WAS READING IN THE LOW RANGE DESPITE THEIR CHILD HAVING A FEVER. THE AGE AND GENDER OF THE PATIENT WAS NOT GIVEN. THE CHILD WAS SEEN BY THEIR DOCTOR AND A FEVER WAS CONFIRMED. THERE WERE NO FURTHER COMPLICATIONS AND THE PATIENT IS DOING WELL NOW. KAZ HAS REQUESTED THAT THE DEVICE BE RETURNED TO OUR COMPANY FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247098 BRAUN THERMOMETER FLL KAZ, INC. IRT-4520

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other