CALMING HEAT WEIGHTED PAD AND MASSAGE 27 SETTING

Description of Event or Problem

THIS REPORT WAS RECEIVED ON (B)(6) 2025 REGARDING A 45-YEAR-OLD FEMALE IN ASSOCIATION WITH THE CALMING HEAT WEIGHTED PAD AND MASSAGE 27 SETTING HEATING PAD. ON (B)(6) 2023, THE CONSUMER LAID A TOWEL ON THE HEATING PAD AND LAID ON IT WHILE IN BED. SHE FELL ASLEEP AND AWOKE THE NEXT MORNING TO DISCOVER SHE HAD A BURN ON HER THIGH. ON (B)(6) 2023, THE CONSUMER NOTED THE AREA WAS STILL NOT HEALED. ON (B)(6) 2023, SHE EMAILED A NURSE PRACTITIONER WHO ADVISED HER THAT THE DARK SCABBING WOULD HAVE TO BE REMOVED AND THAT SHE NEEDED TO BE SEEN. ON (B)(6) 2023, SHE WENT TO AN EMERGENCY ROOM (ER). SHE WAS DIAGNOSED WITH A FULL THICKNESS BURN. HER BURN DIMENSIONS WERE 5 X 9 CM. SHE WAS GIVEN SILVADENE (SILVER SULFADIAZINE) CREAM TO COVER THE AREA WITH GAUZE AND TO CHANGE THE DRESSING DAILY AFTER SHOWERS. SHE WAS ADVISED TO FOLLOW UP WITH A PROVIDER THE FOLLOWING WEEK. SHE WAS STABLE, DID NOT NEED HOSPITAL ADMISSION, AND WAS DISCHARGED FROM THE EMERGENCY ROOM (ER) THE SAME DAY. ON (B)(6) 2023, SHE VISITED A SURGEON. INCISION, DEBRIDEMENT, AND SKIN GRAFTING WITH WOUND VAC THERAPY FOR TREATMENT WAS ADVISED. THE CONSUMER WAS NOT INTERESTED IN SKIN GRAFTING BUT AGREED TO PROCEED WITH INCISION AND DEBRIDEMENT WITH WOUND VAC THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED. CALMING HEAT WEIGHTED PAD AND MASSAGE 27 SETTING.

Additional Manufacturer Narrative

THE IDENTITY OF THE DEVICE WAS NOT VERIFIED - THE CONSUMER HAD NO PHOTOS OR PROOF OF PURCHASE AND INDICATED THAT THEY HAD DISPOSED OF THE DEVICE. 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. THERE IS AN INSTRUCTION THAT STATES, "DO NOT USE WHILE SLEEPING ". THE CONSUMER INDICATED TO US THAT THEY LAY ON TOP OF THE PAD AND FELL ASLEEP.