BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NECK AND SHOULDERS HEATING PAD

    MDR report key: 25175475 · Received May 14, 2026

    Report

    Report Number
    MW5188259
    Event Type
    Malfunction
    Date Received
    May 14, 2026
    Date of Event
    November 15, 2025
    Report Date
    May 11, 2026
    Manufacturer
    NAVAJO MANUFACTURING COMPANY INC.
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT DOES NOT RECALL EXACT DATE BUT REPORTS TAKING THIS HEATING PAD OUT OF THE BOX AROUND WHEN IT WAS DELIVERED TO HER ON (B)(6) 2025, PLUGGING IT INTO AN ELECTRICAL OUTLET AND LEAVING IT ON HER BED. SHE LEFT THE ROOM AND UPON RETURNING TO THE ROOM SHE NOTICED THAT IT WAS SMOKING AND HER IT HAD BURNED A HOLE IN HER BEDSHEET. SHE THEN DISCARDED OF THE HEATING PAD AND DID NOT REPORT ANY INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153150 NECK AND SHOULDERS HEATING PAD PAD, HEATING, POWERED IRT NAVAJO MANUFACTURING COMPANY INC. 02429125607

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Other