BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAUN

    MDR report key: 12311864 · Received August 12, 2021

    Report

    Report Number
    1314800-2021-00016
    Event Type
    Malfunction
    Date Received
    August 12, 2021
    Date of Event
    July 14, 2021
    Report Date
    August 12, 2021
    Manufacturer
    KAZ USA, INC., A HELEN OF TROY COMPANY
    Product Code
    FLL
    UDI-DI
    00328785001297
    PMA / PMN Number
    K103800
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    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 FALSE NEGATIVE READINGS ON HER TEENAGE SON. THE DEVICE ALLEGEDLY GAVE READINGS THAT WERE IN THE MID-80'S, AND A MEASUREMENT OF 101°F WAS LATER MEASURED BY A DOCTOR. THERE WERE NO COMPLICATIONS FROM THIS INCIDENT, AND THE PATIENT IS DOING WELL NOW. KAZ USA, INC. HAD REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1208772 BRAUN EAR THERMOMETER FLL KAZ USA, INC., A HELEN OF TROY COMPANY IRT6520 UNKNOWN 00328785001297

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other| R