CEFALY DUAL MEDICAL DEVICE FOR MIGRAINE SUFFERERS

Description of Event or Problem

I PURCHASED A CEFALY DUAL MEDICAL DEVICE FOR MIGRAINE SUFFERS FOR MY (B)(6) YEAR OLD NIECE ON (B)(6) 2022. SHE USED IT FOR ABOUT 2 MONTHS, 4 OR 5 TIMES A WEEK. SHE STARTED HAVING OLFACTORY HALLUCINATIONS OF CIGARETTE SMOKE OR BURNING ELECTRICAL WIRING. ON OR ABOUT (B)(6) 2021, I CONTACTED CEFALY TECHNOLOGY CUSTOMER SERVICE TO SEE IF THERE WAS ANY CORRELATION TO THE USE ON THE CEFALY DEVICE AND THESE OLFACTORY HALLUCINATIONS. THE NEXT DAY, A CUSTOMER SERVICE REPRESENTATIVE CONTACTED MY NIECE AND TOLD HER TO DISCONTINUE USING IT, AS THERE HAVE BEEN OTHER REPORTS INVOLVING OLFACTORY HALLUCINATIONS. THIS DEVICE IS ADVERTISED AS THE ONLY FDA APPROVED DEVICE FOR TREATMENT OF MIGRAINES. FDA SAFETY REPORT ID # (B)(4).