BEUDAMED
    FDA Adverse Event Death Summary report: N

    BRAUN

    MDR report key: 10423325 · Received August 18, 2020

    Report

    Report Number
    1314800-2020-00033
    Event Type
    Death
    Date Received
    August 18, 2020
    Date of Event
    April 12, 2020
    Report Date
    August 18, 2020
    Manufacturer
    KAZ USA, INC., A HELEN OF TROY COMPANY
    Product Code
    FLL
    UDI-DI
    00328785000559
    PMA / PMN Number
    K134043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A SECOND THERMOMETER WAS RETURNED TO OUR COMPANY BY THE SAME CONSUMER. THE SECOND DEVICE WAS NOT RELATED TO THIS ADVERSE EVENT, AND WAS A DIFFERENT MODEL. THE CONSUMER STATED THAT SHE BELIEVED THAT THE SECOND DEVICE WAS ALSO GIVING FALSE NEGATIVE READINGS. BOTH DEVICES WERE FOUND TO BE WITHIN THE 0.4°F TOLERANCE FOR ACCURACY WHEN TESTED IN OUR LAB.

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT HER THERMOMETER HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON HER STEP-MOTHER. IT WAS ALLEGED THAT THE DEVICE GAVE READINGS THAT WERE 2.5 - 5°F LOWER THAN WHAT WAS LATER MEASURED IN AN AMBULANCE. THE PATIENT WAS ADMITTED INTO A HOSPITAL AND TESTED POSITIVE FOR COVID-19. SHE PASSED AWAY 2 DAYS AFTER BEING ADMITTED INTO THE HOSPITAL. IT WAS ALLEGED THAT THE FALSE NEGATIVE READINGS GIVEN BY THE DEVICE MAY HAVE CAUSED A DELAY IN MEDICAL TREATMENT, BUT THAT SHE DID NOT FEEL WELL FOR SEVERAL DAYS PRIOR TO CALLING AN AMBULANCE. IT WAS STATED THAT THE PATIENT HAD PRE-EXISTING MEDICAL CONDITIONS WHICH PUT HER AT HIGH RISK, AND ALSO STATED THAT CATCHING THE FEVER EARLIER WITH A WORKING THERMOMETER WOULD LIKELY NOT HAVE MADE A DIFFERENCE BUT IT WOULD HAVE BEEN NICE TO KNOW THAT SHE HAD A FEVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886902 BRAUN FOREHEAD THERMOMETER FLL KAZ USA, INC., A HELEN OF TROY COMPANY BFH150 20117TAV 00328785000559

    Patients

    Seq Age Sex Outcome Treatment
    1 Death