BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CALMING HEAT BACK WRAP BASIC

    MDR report key: 24594016 · Received March 13, 2026

    Report

    Report Number
    3003799587-2026-00005
    Event Type
    Injury
    Date Received
    March 13, 2026
    Date of Event
    February 16, 2026
    Report Date
    March 13, 2026
    Manufacturer
    GUANGDONG OKAY TECHNOLOGY CO.,LTD.
    Product Code
    IRT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS AN INSTRUCTION THAT STATES, "BURNS CAN OCCUR REGARDLESS OF CONTROL SETTING, CHECK SKIN UNDER PAD FREQUENTLY", CONSUMER FAILED TO PERFORM THAT INSTRUCTION. THE CUSTOMER INDICATED IN AN EMAIL COMMUNICATION: THERE DOESN'T APPEAR TO BE ANYTHING WRONG WITH THE HEATING PAD.'

    Description of Event or Problem · 0

    ON 23-FEB-2026, THIS REPORT WAS RECEIVED REGARDING A FEMALE CONSUMER IN ASSOCIATION WITH THE CALMING HEAT BACK WRAP. ON (B)(6) 2026, THE CONSUMER APPLIED THE PRODUCT WHILE SITTING IN A RECLINER CHAIR WITH THE HEAT AND MASSAGER SETTINGS ON LOW. AFTER THE MASSAGER STOPPED WORKING, SHE THOUGHT THE AREA FELT A LITTLE WARM, BUT SHE DID NOT THINK ABOUT IT. AFTER 20-25 MINUTES OF TURNING THE PRODUCT ON, THE APPLICATION AREA WAS RED. SHE RUBBED HER BACK, FELT A LITTLE TINGE, AND RUBBED THE AREA. SOME SKIN CAME OFF WHILE SHE POPPED A BURN BLISTER. ON (B)(6) 2026, SHE WENT TO A DOCTOR'S OFFICE AND WAS PRESCRIBED OINTMENT AND ANTIBIOTICS TO HELP HER TO HEAL. AT THE TIME OF THE REPORT, THE REDNESS HAD FADED BUT SHE HAD AN OPEN BURN ON HER BACK. NOTHING APPEARED WRONG WITH THE HEATING PAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657832 CALMING HEAT BACK WRAP BASIC HEATING PAD POWERED IRT GUANGDONG OKAY TECHNOLOGY CO.,LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention