BEUDAMED
    FDA Adverse Event Other Summary report: N

    HANDY SOLUTIONS NECK AND SHOULDERS HEATING PAD WRAP

    MDR report key: 24819529 · Received April 8, 2026

    Report

    Report Number
    1000065475-2026-00010
    Event Type
    Other
    Date Received
    April 8, 2026
    Date of Event
    March 11, 2026
    Report Date
    April 8, 2026
    Manufacturer
    NINGBO UNICO PRODUCTS CO., LTD
    Product Code
    IRT
    UDI-DI
    00024291256076
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IMPORTER SUBMISSION FOR REPORT RECEIVED FROM FDA. REPORT FORWARDED TO MANUFACTURER ON (B)(6) 2026. MW5186416.

    Description of Event or Problem · 0

    PATIENT USED NECK AND BACK HEATING PAD FROM NAVAJO MANUFACTURING COMPANY INC. PRODUCT WAS ITEM #448 FROM (B)(6) OTC CATALOG HEATING PAD WRAP FOR SHOULDER AND NECK. PATIENT FELL ASLEEP ON IT AND WOKE UP TO THE SMELL OF FIRE. PATIENT'S PILLOW HAD A HOLE BURNED INTO IT AND PATIENT HAD A BURN ON HER NECK THAT BLISTERED. PATIENT STOPPED USE IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874961 HANDY SOLUTIONS NECK AND SHOULDERS HEATING PAD WRAP PAD, HEATING, POWERED IRT NINGBO UNICO PRODUCTS CO., LTD 25607 00024291256076

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Other