BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALNUT CARES

    MDR report key: 17948918 · Received October 17, 2023

    Report

    Report Number
    3015140201-2023-00002
    Event Type
    Injury
    Date Received
    October 17, 2023
    Date of Event
    February 12, 2023
    Report Date
    April 17, 2023
    Manufacturer
    SHENZHEN TESLONG TECHNOLOGY CO., LTD
    Product Code
    FLL
    Removal / Correction Number
    92275
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    LETTER FROM CONSUMER RECEIVED ON APRIL 17, 2023, SUGGESTING THAT ON (B)(6) 2023, A CHILD WEARING THE PRODUCT SUFFERED THIRD-DEGREE BURNS TO THE CHEST, WHICH THEY BELIEVE WAS CAUSED BY THE PRODUCT'S BATTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96388 WALNUT CARES WALNUT WEARABLE SMART THERMOMETER FLL SHENZHEN TESLONG TECHNOLOGY CO., LTD WT20 20221115W002

    Patients

    Seq Age Sex Outcome Treatment
    1 9 MO Male Other| H