BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALNUT CARES

    MDR report key: 17948905 · Received October 17, 2023

    Report

    Report Number
    3015140201-2023-00001
    Event Type
    Injury
    Date Received
    October 17, 2023
    Report Date
    April 28, 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
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    ON APRIL 27, BEARCARE SENT AN AMAZON NOTIFICATION TO ALL CONSUMER WHO HAD PURCHASED THROUGH AMAZON INFORMING CONSUMERS OF POTENTIAL SAFETY CONCERNS AND ADVISING TO CEASE USE OF THE PRODUCT. ON (B)(6) 2023, A CONSUMER WHO PURCHASED THE PRODUCT ON (B)(6) 2023, REPLIED SAYING THAT HER NEPHEW "WAS BURN (SIC) USING IT." NO FURTHER DETAILS WERE PROVIDED BY THE CONSUMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2055155 WALNUT CARES WALNUT WEARABLE SMART THERMOMETER FLL SHENZHEN TESLONG TECHNOLOGY CO., LTD WT20 20221115W002

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other