CALMING HEAT BACK WRAP BASIC

Description of Event or Problem

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.

Additional Manufacturer Narrative

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.