BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CALMING HEAT BACK WRAP BASIC

    MDR report key: 24627118 · Received March 18, 2026

    Report

    Report Number
    3003799587-2026-00007
    Event Type
    Injury
    Date Received
    March 18, 2026
    Report Date
    April 14, 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" - CONSUMER FAILED TO PERFORM THAT INSTRUCTION.

    Additional Manufacturer Narrative · 0

    FOLLOW-UP REPORT TO INCLUDE ADDITIONAL INFORMATION RECEIVED FROM THE COMPLAINANT. THE COMPLAINANT NOW ALLEGES THAT THE DEVICE DID NOT AUTOMATICALLY SHUT OFF AFTER APPROXIMATELY 4 HOURS OF USE. THIS INFORMATION WAS NOT INCLUDED IN THE INITIAL REPORT AND IS INCONSISTENT WITH THE ORIGINAL STATEMENT INDICATING: "I WAS USING THE WRAP FOR A TOTAL OF 4 HOURS. THERE WERE TIMES WHERE IT WAS OFF BETWEEN THE FOUR HOURS IT WAS ON LOW AND MEDIUM HEAT." THE DEVICE HAS NOT BEEN RETURNED FOR INSPECTION DESPITE MULTIPLE REQUESTS; THEREFORE, NO EVALUATION OR FUNCTIONAL TESTING COULD BE PERFORMED. BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION CANNOT BE CONFIRMED. FURTHERMORE, THERE IS AN INSTRUCTION THAT STATES: "BURNS CAN OCCUR REGARDLESS OF CONTROL SETTING, CHECK SKIN UNDER PAD FREQUENTLY". THE CONSUMER FAILED TO PERFORM THAT INSTRUCTION.

    Description of Event or Problem · 0

    ON 07-FEB-2023, THIS REPORT WAS RECEIVED FROM A FEMALE (AGE NOT PROVIDED) IN ASSOCIATION WITH THE CALMING HEAT BACK WRAP. ON AN UNSPECIFIED DATE THE CONSUMER APPLIED THE CALMING HEAT BACK WRAP. AFTER USING THE HEAT WRAP, THE CONSUMER NOTED THE PRODUCT'S HEAT SETTING AUTO SHUT OFF. THE CONSUMER NOTED THE HEATING PAD WAS SET FOR LOW AND MEDIUM HEAT. THERE WERE TIMES IT WAS OFF. SHE CLARIFIED IT SHUT OFF LESS THAN AFTER 2 HOURS. SHE USED THE PRODUCT FOR A TOTAL OF 4 HOURS. AFTER USING THE PRODUCT, SHE NOTED SHE HAD A THIRD-DEGREE BURN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    ON 20-MAR-2026, ADDITIONAL INFORMATION WAS RECEIVED. THE CONSUMER USED THE PRODUCT ON HER BACK WHILE WORKING FOR HOME. SHE REPORTED THE AUTO SHUT OFF NEVER OCCURRED AFTER APPROXIMATELY 4 HOURS OF USE. SHE EXPERIENCED A 3RD DEGREE BURN WITH A BLISTER. SHE WENT TO AN URGENT CARE AND WAS PRESCRIBED SILVADENE CREAM SINCE THE BLISTER HAD ALREADY POPPED. THE BURN TOOK A COUPLE OF WEEKS TO RESOLVE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532975 CALMING HEAT BACK WRAP BASIC HEATING PAD POWERED IRT GUANGDONG OKAY TECHNOLOGY CO.,LTD. 06936189900715

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention