BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    HANDY SOLUTIONS

    MDR report key: 25250793 · Received May 21, 2026

    Report

    Report Number
    3030539818-2026-00015
    Event Type
    Malfunction
    Date Received
    May 21, 2026
    Date of Event
    March 25, 2026
    Report Date
    March 25, 2026
    Manufacturer
    NINGBO UNICO PRODUCTS CO., LTD 
    Product Code
    IRT
    UDI-DI
    00024291256076
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 (B)(4)) AND NO DEFECTS IDENTIFIED. THIRD PART TESTING REPORT (B)(4).

    Description of Event or Problem · 0

    HEATING PAD MADE BY VAVAJO MANUFACTURING COMPANY INC. OVERHEATED AND BURNED THROUGH THE FABRIC OF THE HEATING PAD. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160541 HANDY SOLUTIONS PAD, HEATING, POWERED IRT NINGBO UNICO PRODUCTS CO., LTD  25607 V1 00024291256076

    Patients

    Seq Age Sex Outcome Treatment
    1