BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    HEATING PAD WRAP FOR SHOULDER AND NECK

    MDR report key: 25107872 · Received May 6, 2026

    Report

    Report Number
    3030539818-2026-00011
    Event Type
    Injury
    Date Received
    May 6, 2026
    Date of Event
    March 11, 2026
    Report Date
    April 8, 2026
    Manufacturer
    NINGBO UNICO PRODUCTS CO., LTD 
    Product Code
    IRT
    UDI-DI
    00024291256076
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER RECEIVED A REPORT STATING THAT THE HEATING PAD OVERHEATED, ALONG WITH PHOTOS OF THE INCIDENT. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE PRODUCT LABEL WARNED AGAINST USE ON SOFT SURFACE AND CAN'T BE COVERED DURING USE, YET THESE ACTIONS WERE OBSERVED IN THE INCIDENT PHOTOS. THIRD-PARTY TESTING CONFIRMED THE PRODUCT DOES NOT OVERHEAT UNDER CORRECT USE (SEE TEST REPORT: (B)(4) AND NO DEFECTS IDENTIFIED. FROM THE DESCRIBE EVENT, WE KNOW THE PATIENT FELL ASLEEP ON IT, THAT DIDN'T CONFORM TO THE CORRECT USAGE METHOD.

    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 BLISTERD. PATIENT STOPPED USE IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494526 HEATING PAD WRAP FOR SHOULDER AND NECK PAD, HEATING, POWERED IRT NINGBO UNICO PRODUCTS CO., LTD  25607 V1 00024291256076

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention