BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALNUT CARE

    MDR report key: 17949354 · Received October 17, 2023

    Report

    Report Number
    3015140201-2023-00003
    Event Type
    Injury
    Date Received
    October 17, 2023
    Date of Event
    April 11, 2023
    Report Date
    April 11, 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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    EMAIL RECEIVED FORM CONSUMER DATED APRIL 11, 2023, SUGGESTING THAT ON (B)(6) 2023, A CHILD WEARING THE PRODUCT SUFFERED SIGNIFICANT SKIN BURNS. THE COMPLAINT ALLEGED THAT THE CHILD WAS ASLEEP WHILE WEARING THE PRODUCT. UNKNOWN AT THIS TIME WHETHER MEDICAL ATTENTION WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2078409 WALNUT CARE WALNUT WEARABLE THERMOMETER FLL SHENZHEN TESLONG TECHNOLOGY CO., LTD WT20 20221115W002

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Male Other