BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALNUT THERMOMETER

    MDR report key: 16763797 · Received April 17, 2023

    Report

    Report Number
    MW5116762
    Event Type
    Injury
    Date Received
    April 17, 2023
    Date of Event
    April 10, 2023
    Report Date
    April 12, 2023
    Manufacturer
    UNK
    Product Code
    FQZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A 2 YEAR OLD CHILD WAS WEARING A WALNUT CARES WEARABLE BLUETOOTH THERMOMETER TO MONITOR TEMPERATURE WHILE SLEEPING FOR A COMMON COLD. UPON REMOVING THE THERMOMETER IN THE MORNING, CORROSION WAS NOTICED AROUND THE CONTACT SENSOR AND CHARGING CONTACTS, SIMILAR TO BATTERY ACID. WE IMMEDIATELY CHECKED THE CHILD'S SKIN AND DISCOVERED A BLISTERED AND SCABBED CHEMICAL BURN WITH SIGNIFICANT REDNESS AND IRRITATION AROUND THE BURN SITE. IT APPEARS THE BATTERY INSIDE THE WALNUT DEVICE RUPTURED DURING WEAR AND CAUSED A CHEMICAL BURN. WE TOOK THE CHILD TO THEIR PCP, WHO CONFIRMED A 2ND DEGREE CHEMICAL BURN CAUSED BY THE DEVICE. WE HAVE REACHED OUT TO WALNUT CARES VIA THEIR CUSTOMER CONTACT EMAIL ([email protected]) AND HAVE NOT RECEIVED A RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1372525 WALNUT THERMOMETER THERMOMETER, CLINICAL COLOR CHANGE FQZ UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 24 MO Male Required Intervention| O ZYRTEC