CALMING HEAT BACK WRAP BASIC

Additional Manufacturer Narrative

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

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.