BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    HANDY SOLUTIONS

    MDR report key: 24511488 · Received March 4, 2026

    Report

    Report Number
    3030539818-2026-00003
    Event Type
    Injury
    Date Received
    March 4, 2026
    Date of Event
    January 22, 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

    USER STATES THE SECOND TIME SHE USED IT, SOMETHING SMELLED HOT. DID NOT STATE IT CAUGHT ON FIRE, BUT SHE DID STATE HER BACK WAS BURNED AND BLISTERED. WENT TO THE ER, GOING TO BURN AND WOUND PLASTIC SURGERY CENTER ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91555 HANDY SOLUTIONS PAD,HEATING,POWERED IRT NINGBO UNICO PRODUCTS CO., LTD 25607 V1 00024291256076

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Unknown Required Intervention