BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATING PAD FOR SHOULDER & NECK

    MDR report key: 24757048 · Received April 1, 2026

    Report

    Report Number
    MW5186233
    Event Type
    Malfunction
    Date Received
    April 1, 2026
    Date of Event
    February 27, 2026
    Report Date
    March 27, 2026
    Manufacturer
    NAVAJO MANUFACTURING COMPANY INC
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT CALLED TO REPORT RECEIVING LETTER ADVISING OF OVERHEATING ISSUE WITH HEATING PAD (OTC #448) PURCHASED FROM (B)(6) PHARMACY OTC DEPARTMENT. PATIENT STATES SHE USED THE HEATING PAD A FEW TIMES SINCE (B)(6) 2025. PATIENT STATES SHE LIVES IN (B)(6) THEREFORE DOES NOT NEED TO USE HEATING PAD MUCH DUE TO (B)(6) WARM TEMPERATURES. PATIENT STATES SHE NOTICED BURN MARKS ON MATTRESS 3 TO 4 WEEKS AGO. PATIENT STATES SHE DID NOT REPORT IT BECAUSE SHE THOUGHT IT WAS A "FLUKE." PATIENT STATES SHE DECIDED TO REPORT INCIDENT, AFTER RECEIVING LETTER NOTIFYING HER OF AN OVERHEATING DEFECT OF THE PAD EXPLAINED IN THE LETTER FROM (B)(6). PATIENT REQUESTING REPLACEMENT OF HER MATTRESS. PATIENT DID NOT SUFFER ANY PERMANENT BODILY INJURY. PATIENT STATES SHE STILL HAS THE MATTRESS AND HEATING PAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811653 HEATING PAD FOR SHOULDER & NECK PAD, HEATING, POWERED IRT NAVAJO MANUFACTURING COMPANY INC

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female