BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANDY SOLUTIONS

    MDR report key: 24261000 · Received February 4, 2026

    Report

    Report Number
    1000065475-2026-00001
    Event Type
    Injury
    Date Received
    February 4, 2026
    Date of Event
    January 7, 2026
    Report Date
    February 4, 2026
    Manufacturer
    NINGBO UNICO PRODUCTS CO., LTD FLOOR.3TH, BUILDING
    Product Code
    IRT
    UDI-DI
    00024291256076
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    CONSUMER WAS USING HANDY SOLUTIONS NECK AND SHOULDER HEATING PAD WHILE LAYING IN BED. SHE NOTICED A BURNING SMELL AND FOUND THAT THE HEATING PAD HAD BURNT THROUGH AND BURNED THE BACK OF HER NECK. SHE DID NOT SEEK MEDICAL ATTENTION FOR THE BURN AS IT WAS MINOR. TESTING WAS DONE ON OTHER UNITS AND DETERMINED THAT WHEN THE PAD IS LAID ON OR BENT IN WAYS THAT ARE RECOMMENDED AGAINST IN THE INSTRUCTIONS FOR THE DEVICE THAT OVERHEATING CAN OCCUR AND CAUSE DAMAGE/BURNING OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318798 HANDY SOLUTIONS PAD, HEATING, POWERED IRT NINGBO UNICO PRODUCTS CO., LTD FLOOR.3TH, BUILDING 25607 00024291256076

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Other