CALMING HEAT WEIGHTED HEATING PAD AND MASSAGE PAD

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. THERE IS AN INSTRUCTION THAT STATES, "DO NOT SIT ON, AGAINST, OR CRUSH PAD-AVOID SHARP FOLDS. PLACE PAD ON TOP OF AND NOT UNDER THE PART OF BODY NEEDING HEAT" AND CONSUMER FAILED TO PERFORM THAT INSTRUCTION.

Description of Event or Problem

ON (B)(6) 2023, THIS REPORT WAS RECEIVED REGARDING A FEMALE CONSUMER (AGE NOT PROVIDED) IN ASSOCIATION WITH THE CALMING HEAT WEIGHTED HEATING PAD AND MASSAGE PAD. ON AN UNSPECIFIED DATE IN 2022 OR 2023, THE CONSUMER USED THE PRODUCT ON HER SIDE. SHE EXPERIENCED THIRD DEGREE BURNS ON THE RIGHT BREAST. SHE HAD AN OPEN WOUND AND PAIN. SHE INDICATED SHE WOULD HAVE TO SEE THE DOCTORS AGAIN BECAUSE IT WAS NOT HEALING PROPERLY. ON AN UNSPECIFIED DATE SHE VISITED THE DOCTOR AND REPORTED HAVING UNSPECIFIED MEDICATIONS AND TREATMENTS. FOLLOW-UP ATTEMPTS WERE COMPLETED, BUT NO ADDITIONAL INFORMATION WAS RECEIVED.