CONAIR

Description of Event or Problem

(B)(6) 2025 - THE CONSUMER REPORTED RECEIVING BLISTERS ON HER BACK WHILE USING THE DEVICE. THE CONSUMER CONFIRMED THAT SHE FELL ASLEEP WHILE LAYING ON TOP OF THE DEVICE.

Additional Manufacturer Narrative

(B)(6) 2025 - A MEDICAL DEVICE REPORT WILL BE SUBMITTED TO THE US FDA. THE CONSUMER DID NOT PROVIDE THEIR CONTACT INFORMATION, SO WE WILL NOT BE ABLE TO RETRIEVE THE PRODUCT FOR INVESTIGATION. BASED ON THE CONSUMER'S DESCRIPTION OF THE EVENT, CONSIDERING THAT THE CONSUMER FELL ASLEEP WHILE USING THE PRODUCT, THE BLISTERS WERE LIKELY DUE TO IMPROPER USE OF THE DEVICE. CONSUMERS ARE WARNED NOT TO LIE ON THE DEVICE AND ARE ADVISED TO CHECK THEIR SKIN FREQUENTLY TO AVOID BURNS.