CEFALY

Description of Event or Problem

THIS INCIDENT OCCURRED IN CANADA. THERE IS NO EVIDENCE INDICATING THAT IT MEETS THE CRITERIA FOR A REPORTABLE MEDICAL DEVICE INCIDENT. THE REPORTING IS CONDUCTED BASED ON THE PRECAUTIONARY PRINCIPLE. DATE OF INCIDENT: EXACT DATE NOT YET CONFIRMED; THE INCIDENT OCCURRED PRIOR TO (B)(6) 2026. DESCRIPTION OF THE EVENT: ACCORDING TO THE CUSTOMER REPORT: THE USER COMPLETED A 20-MINUTE TREATMENT SESSION USING THE DEVICE. NO ABNORMALITIES WERE OBSERVED DURING THE TREATMENT SESSION. APPROXIMATELY 10 MINUTES AFTER COMPLETING THE TREATMENT, THE DEVICE WAS PLACED ON THE CHARGING DOCK. THE DEVICE APPEARED TO BEGIN CHARGING NORMALLY. AFTER APPROXIMATELY 45-60 MINUTES OF CHARGING, THE CUSTOMER REPORTED HEARING A "POP" SOUND ORIGINATING FROM THE DEVICE FOLLOWED BY THE DETECTION OF AN ODOR OF BURNING PLASTIC. DEVICE USE INFORMATION: BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER: THE ORIGINAL USB CABLE SUPPLIED WITH THE DEVICE WAS USED. THE DEVICE HAD NOT PREVIOUSLY BECOME WARM OR OVERHEATED DURING CHARGING. THE DEVICE WAS CONNECTED TO THE SAME ELECTRICAL OUTLET NORMALLY USED FOR CHARGING. THE CUSTOMER REPORTED THAT THE ADAPTOR USED WAS THE ORIGINAL ADAPTOR PROVIDED WITH THE DEVICE. HOWEVER, CEFALY DEVICES ARE SOLD WITHOUT A POWER ADAPTOR. BASED ON PHOTOGRAPHS PROVIDED BY THE CUSTOMER, THE ADAPTOR USED DOES NOT APPEAR TO BE MANUFACTURED BY CEFALY AND DOES NOT APPEAR TO MEET THE CHARGING SPECIFICATIONS DESCRIBED IN THE USER MANUAL. THE DEVICE HAD REPORTEDLY BEEN CHARGED USING THE SAME ACCESSORIES SINCE (B)(6) 2025. THE CUSTOMER WAS REQUESTED TO RETURN THE DEVICE, ALONG WITH THE ADAPTOR, CABLE, AND CHARGING DOCK USED, FOR INVESTIGATION. AS OF THE REPORTING DATE, THE ITEMS HAVE NOT BEEN RECEIVED.