BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CALMING HEAT BACK WRAP BASIC

    MDR report key: 24627097 · Received March 18, 2026

    Report

    Report Number
    3003799587-2026-00006
    Event Type
    Injury
    Date Received
    March 18, 2026
    Date of Event
    April 23, 2023
    Report Date
    March 18, 2026
    Manufacturer
    GUANGDONG OKAY TECHNOLOGY CO.,LTD.
    Product Code
    IRT
    UDI-DI
    06936189900715
    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" AND CONSUMER FAILED TO PERFORM THAT INSTRUCTION.

    Description of Event or Problem · 0

    THIS REPORT WAS RECEIVED ON (B)(6) 2023 WHICH REGARDED A FEMALE CONSUMER (AGE NOT PROVIDED) IN ASSOCIATION WITH THE CALMING HEAT BACK WRAP. ON (B)(6) 2023, THE CONSUMER USED A CALMING HEAT BACK WRAP. WHILE USING THE PRODUCT SHE FELT A BURNING SENSATION ON HER BACK. SHE REMOVED THE HEAT WRAP AND DISCOVERED SHE HAD A QUARTER SIZED BLISTER ON THE RIGHT SIDE OF HER BACK. SHE WAS TRANSPORTED TO THE HOSPITAL. SHE WAS NOTED TO HAVE SECOND DEGREE BURNS. SHE WAS ADMITTED AND DISCHARGED FROM THE HOSPITAL ON THE SAME DAY ON (B)(6) 2023. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688038 CALMING HEAT BACK WRAP BASIC PAD, HEATING, POWERED IRT GUANGDONG OKAY TECHNOLOGY CO.,LTD. 06936189900715

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention