CEFALY

Additional Manufacturer Narrative

THE TEAM HAS SENT THE DEVICE TO THE FACTORY FOR ANALYSIS. EFFORTS ARE ALSO UNDERWAY TO REACH OUT TO THE USER TO GATHER THE PATIENT'S DETAILS AS OUTLINED IN SECTION A. IT'S IMPORTANT TO NOTE THAT THE AGE AND WEIGHT INFORMATION WE HAVE NOW IS ESTIMATED AND WILL BE CONFIRMED DIRECTLY WITH THE PATIENT. PLEASE NOTE THAT THIS INFORMATION MAY BE UPDATED.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THEY DISCOVERED THE DEVICE WAS MELTED OVERNIGHT WHILE CHARGING . CUSTOMER SAID LAST USED THE DEVICE LAST WEEK OF THE INCIDENT AND AT THAT TIME THE DEVICE WERE FINE.