BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINSA SMART STICK THERMOMETER

    MDR report key: 15066958 · Received July 19, 2022

    Report

    Report Number
    MW5110970
    Event Type
    Malfunction
    Date Received
    July 19, 2022
    Date of Event
    July 14, 2022
    Report Date
    July 15, 2022
    Manufacturer
    KINSA INC.
    Product Code
    FLL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAVE A KINSA SMART STICK THERMOMETER AND THE TEMPERATURE THAT IT REPORTS IS ALWAYS HIGHER THAN THE TEMPERATURE I GET FROM A TRADITIONAL MERCURY THERMOMETER OR A DIGITAL THERMOMETER. THE TEMPERATURE IS RANDOMLY HIGH SO YOU CAN TAKE TWO READINGS AND THE READINGS WILL BE DIFFERENT EVEN WITHIN THE SAME MINUTE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252326 KINSA SMART STICK THERMOMETER THERMOMETER, ELECTRONIC, CLINICAL FLL KINSA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Male