BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANDY SOLUTIONS

    MDR report key: 25250529 · Received May 21, 2026

    Report

    Report Number
    3030539818-2026-00012
    Event Type
    Injury
    Date Received
    May 21, 2026
    Date of Event
    February 27, 2026
    Report Date
    March 27, 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

    PATIENT CALLED TO REPORT RECEIVING LETTER ADVISING OF OVERHEATING ISSUE WITH HEATING PAD (OTC#448) PURCHASED FROM PHARMACY OTC DEPARTMENT. PATIENT STATES SHE USED THE HEATING PAD A FEW TIMES SINCE 2025. PATIENT STATES SHE LIVES IN, THEREFORE DOES NOT NEED TO USE HEATING PAD MUCH DUE TO WARM TEMPERATURES. PATIENT STATES SHE NOTICED BURN MARKS ON MATTRESS 3 TO 4 WEEKS AGO. PATIENT STATES SHE DID NOT REPORT IT BECAUSE SHE THOUGHT IT WAS A "FLUKE". PATIENT STATES SHE DECIDED TO REPORT INCIDENT, AFTER RECEIVING LETTER NOTIFYING HER OF AN OVERHEATING DEFECT OF THE PAD EXPLAINED IN THE LETTER FROM. PATIENT REQUESTING REPLACEMENT OF HER MATTRESS. PATIENT DID NOT SUFFER ANY PERMANENT BODILY INJURY. PATIENT STATES SHE STILL HAS THE MATTRESS AND HEATING PAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321105 HANDY SOLUTIONS PAD, HEATING, POWERED IRT NINGBO UNICO PRODUCTS CO., LTD  25607 V1 00024291256076

    Patients

    Seq Age Sex Outcome Treatment
    1