BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANDY SOLUTIONS

    MDR report key: 24814215 · Received April 8, 2026

    Report

    Report Number
    3030539818-2026-00007
    Event Type
    Injury
    Date Received
    April 8, 2026
    Date of Event
    January 15, 2026
    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

    HEATING PAD OVERHEATED AND CAUSED BURNS ON SHOULDERS. THE PRODUCT MELTED ITS OWN SWITCH AND NEEDED TO BE UNPLUGGED/COULD NOT BE SHUT OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878068 HANDY SOLUTIONS NECK AND SHOULDER HEATING PAD IRT NINGBO UNICO PRODUCTS CO., LTD  25607 V1 00024291256076

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Unknown Required Intervention