BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMBAR & NECK REVOLVING PULSE HEAT THERAPY CUSHION

    MDR report key: 23391171 · Received October 27, 2025

    Report

    Report Number
    MW5178005
    Event Type
    Injury
    Date Received
    October 27, 2025
    Date of Event
    July 25, 2025
    Report Date
    October 21, 2025
    Manufacturer
    UNKNOWN
    Product Code
    IRT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE "LUMBAR & NECK REVOLVING PULSE HEAT THERAPY CUSHION" I PURCHASED IT ON (B)(6) 2025. I USED IT LAST ON (B)(6) 2025, BETWEEN 9-10PM AND THE PRODUCT BRUISED/BURNED ME AND LEFT A SCAR. I WENT TO THE ER ON (B)(6) 2025 WHERE I WAS EVALUATED, I ALSO BROUGHT THE MEDICAL DEVICE WITH ME, AND THE PROVIDER STATED THAT THE HEATING ELEMENT MIGHT HAVE WENT OUT ON IT THAT IS USED TO KEEP IT FROM OVERHEATING. I REPORTED THIS ISSUE TO SAFER PRODUCTS.GOV ON (B)(6) 2025 AND THEY ADVISED IN A LETTER/EMAIL THAT THIS IS MORE AN FDA ISSUE. REPORT NO. (B)(4). I BOUGHT THE PRODUCT ON FSA.COM BY CARING MILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2794998 LUMBAR & NECK REVOLVING PULSE HEAT THERAPY CUSHION PAD, HEATING, POWERED IRT UNKNOWN CM4000M

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Required Intervention ELDERBERRY.| WOMEN'S ONE A DAY GUMMY.