BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANDY SOLUTIONS

    MDR report key: 24814196 · Received April 8, 2026

    Report

    Report Number
    3030539819-2026-00006
    Event Type
    Injury
    Date Received
    April 8, 2026
    Date of Event
    November 26, 2025
    Report Date
    February 12, 2026
    Manufacturer
    NINGBO UNICO PRODUCTS CO., LTD
    Product Code
    IRT
    UDI-DI
    00024291256076
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER RECEIVED A REPORT STATING THAT THE HEATING PAD OVERHEATED, ALONG WITH PHOTOS OF THE INCIDENT.THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE PRODUCT LABEL WARNED AGAINST USE ON SOFT SURFACE AND CAN'T BE COVERED DURING USE,YET THESE ACTIONS WERE OBSERVED IN THE INCIDENT PHOTOS. THIRD-PARTY TESTING CONFIRMED THE PRODUCT DOES NOT OVERHEAT UNDER CORRECT USE (SEE TEST REPORT ZX260209-C060401) AND NO DEFECTS IDENTIFIED.

    Description of Event or Problem · 0

    USER STATED THE SWITCH GETS SO HOT AFTER BEING TURNED ON 10 MIN OR SO, THAT IT'S TOO HOT TO TOUCH. HE GOT BURNED BY TRYING TO TURN IT OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875785 HANDY SOLUTIONS NECK & SHOULDER HEATING PAD IRT NINGBO UNICO PRODUCTS CO., LTD 25607 V1 00024291256076

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Unknown Required Intervention