CALMING HEAT WEIGHTED HEATING PAD AND MASSAGE PAD 18 SETTING

Additional Manufacturer Narrative

THE EVENT REPORTED BY THE CONSUMER COULD NOT BE REPLICATED UPON EVALUATION OF THE RETURNED UNIT. THE CABLE AND THE CONNECTOR SHOW SIGNS OF DAMAGE THAT OCCURRED AFTER RECEIPT OF THE PRODUCT. IT IS CLEARLY STATED IN THE PRODUCT INSTRUCTION MANUAL THAT THE ITEM SHOULD BE DISCARDED IF IT SHOWS ANY SIGN OF DETERIORATION, WEAR, OR DAMAGE. ON THE PAD ITSELF, THERE IS AN INSTRUCTION THAT STATES: "CHECK THE SKIN UNDER THE PAD FREQUENTLY TO AVOID BURNING". PLEASE NOTE, ALLSTAR IS REPORTING THIS EVENT AS WE ARE COMMITTED TO FDA COMPLIANCE. OUR INVESTIGATION CONCLUDES THAT THE INCIDENT WAS NOT THE RESULT OF A MALFUNCTIONING DEVICE.

Description of Event or Problem

ON 29-AUG-2025, ALLSTAR MARKETING GROUP RECEIVED THE FOLLOWING REPORT REGARDING A 37-YEAR-OLD FEMALE CONSUMER IN ASSOCIATION WITH THE CALMING HEAT WEIGHTED HEATING PAD AND MASSAGE PAD. ON (B)(6) 2025, A FEW TIMES AFTER USING THE PRODUCT, THE CONSUMER PLUGGED THE PRODUCT IN AND APPLIED IT ACROSS HER STOMACH DURING HER CYCLE TO RELIEVE HER CRAMPS. AFTER APPROXIMATELY 10 MINUTES OF PRODUCT APPLICATION, SHE NOTICED THE FABRIC AREA WAS NOT WARM, BUT THE CONNECTOR WAS HOT. SHE UNPLUGGED THE CALMING HEAT WEIGHTED HEATING PAD AND MASSAGE PAD. LATER THAT DAY, THE SKIN ON HER RIGHT HIP WAS RED, BLISTERED, AND PAINFUL. SHE WENT TO AN EMERGENCY ROOM. SHE WAS TREATED WITH TYLENOL (ACETAMINOPHEN) WITH CODEINE FOR A SECOND-DEGREE BURN. SHE WAS TO APPLY NEOSPORIN TO THE AREA AND TO COVER WITH GAUZE. AT THE TIME OF THE REPORT, SHE EXPERIENCED PAIN AND HAD NOT WORKED FOR THREE DAYS.