BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATING PAD WRAP FOR SHOULDER AND NECK

    MDR report key: 24799435 · Received April 7, 2026

    Report

    Report Number
    MW5186416
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Date of Event
    March 11, 2026
    Report Date
    April 2, 2026
    Manufacturer
    NAVAJO MANUFACTURING COMPANY INC.
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT USED NECK AND BACK HEATING PAD FROM NAVAJO MANUFACTURING COMPANY INC. PRODUCT WAS ITEM #448 FROM HUMANA 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
    860314 HEATING PAD WRAP FOR SHOULDER AND NECK PAD, HEATING, POWERED IRT NAVAJO MANUFACTURING COMPANY INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Other