CONAIR

Additional Manufacturer Narrative

9/17/2025 - THE CONSUMER HAS RETURNED THE DEVICES FOR AN INVESTIGATION. THE INVESTIGATION IS CURRENTLY IN PROGRESS AND A SUPPLEMENTAL MDR WILL BE SUBMITTED.

Description of Event or Problem

THE CONSUMER CLAIMS TO HAVE RECEIVED A BLISTER WHILE SITTING ON THE PRODUCT. THE CONSUMER USED THE PRODUCT FOR 10 MINUTES AND THE NEXT DAY FELT A BLISTER WHICH WAS BURNING AND STINGING.

Description of Event or Problem

THE CONSUMER CLAIMS TO HAVE RECEIVED A BLISTER WHILE SITTING ON THE PRODUCT. THE CONSUMER USED THE PRODUCT FOR 10 MINUTES AND THE NEXT DAY FELT A BLISTER WHICH WAS BURNING AND STINGING.

Additional Manufacturer Narrative

(B)(6) 2025 - THE CONSUMER HAS RETURNED THE DEVICES FOR AN INVESTIGATION. THE INVESTIGATION IS CURRENTLY IN PROGRESS AND A SUPPLEMENTAL MDR WILL BE SUBMITTED. (B)(6) 2025 - THE INVESTIGATION HAS BEEN COMPLETED. BELOW IS THE MANUFACTURERS NARRATIVE: MANUFACTURERS NARRATIVE: BASED ON THE IB, THE CONSUMER IS TO NOT SLEEP WHILE USING THE HEATING PAD. THEY ARE ALSO NOT TO SIT ON THE HEATING PAD DURING USE. THE CONSUMER STATES THAT THEY SLEPT WITH THE HEATING PAD AS WELL AS SITTING WITH THE HEATING PAD BEHIND THEIR BACK. THE CONSUMER ALSO STATED THAT THE UNIT HAD AN AUTO OFF FEATURE. HOWEVER, THIS UNIT DOES NOT. THE PRODUCT WAS TESTED IN ACCORDANCE WITH THE SPECIFICATIONS, AND NO ISSUES WERE IDENTIFIED DURING TESTING. BASED ON THE INVESTIGATION, THE REPORTED ISSUE APPEARS TO BE THE RESULT OF CONSUMER MISUSE. THE CONSUMER STATED THAT THEY FELL ASLEEP WHILE USING THE PRODUCT ON THEIR BACK IN A SEATED POSITION. ADDITIONALLY, THE CONSUMER ASSUMED THE PRODUCT HAD AN AUTOMATIC SHUT-OFF FEATURE, WHICH THIS MODEL DOES NOT INCLUDE. HOWEVER, THIS DOES CHANGE THE INDICATIONS FOR USE; THE PRODUCT'S INSTRUCTIONS CLEARLY WARN AGAINST USING THE DEVICE WHILE SITTING OR LYING DOWN AND ADVISE CONSUMERS NOT TO SLEEP DURING USE.