UTK

Additional Manufacturer Narrative

THIS ADVERSE EVENT INFORMATION WAS SOURCED FROM A PUBLIC AMAZON CUSTOMER REVIEW (REVIEW ID: (B)(4) DATED ON (B)(6) 2025. MODEL: H11S2, SMOKED DURING NORMAL REPEATED USE. THE PLUG AREA TEMPERATURE EXCEEDED 250°F MEASURED BY HEAT GUN, WHICH CAUSED SKIN BURN INJURY TO THE END USER AND SCORCHED BED SHEETS. RECURRENCE OF THIS OVERHEATING FAILURE CREATES POTENTIAL FIRE HAZARD. THE MANUFACTURER CANNOT CONTACT THE ANONYMOUS CUSTOMER TO RETRIEVE THE FAILED UNIT OR COLLECT FURTHER CLINICAL AND DEVICE INSPECTION DETAILS. NO CORRECTIVE OR REMEDIAL ACTIONS HAVE BEEN INITIATED TO DATE. THE PRODUCT IS 510(K) EXEMPT REUSABLE THERMAL THERAPY DEVICE. SINCE SPECIFIC HEATING ELEMENT COMPONENT CODE IS UNAVAILABLE IN THIS SOFTWARE LIBRARY, HEAT EXCHANGER IS SELECTED AS THE EQUIVALENT THERMAL COMPONENT CATEGORY TO REPRESENT THE INTERNAL HEATING WIRE OF THE THERMAL THERAPY PAD WHICH CAUSED OVERHEATING FAILURE.

Description of Event or Problem

MODEL: H11S2, INCIDENT DATE: ON (B)(6) 2025. DEVICE SMOKED DURING USE, PLUG AREA TEMPERATURE OVER 250°F MEASURED BY HEAT GUN, CAUSED USER SKIN BURN AND BURNT BED SHEETS. FIRE HAZARD EXISTS IF FAILURE RECURS. THIS FEEDBACK WAS OBTAINED FROM PUBLIC AMAZON CUSTOMER REVIEW (REVIEW ID: (B)(4), AND THE CONSUMER CANNOT BE CONTACTED FOR FURTHER FOLLOW-UP INFORMATION. INTERNAL CASE NO. (B)(4).