CEFALY DEVICE

Description of Event or Problem

I HAVE SUFFERED FROM EPISODIC MIGRAINES FOR THE LAST 20 YEARS. MOST OF MY MIGRAINES START DIRECTLY ABOVE MY RIGHT EYEBROW, A BRANCH OF THE TRIGEMINAL NERVE. UPON LEARNING ABOUT THE FDA APPROVED WITHOUT A PRESCRIPTION CEFALY DEVICE (A TRIGEMINAL NERVE STIMULATOR), I DECIDED TO GIVE IT A TEST SINCE THERE WAS A 60-DAY TRIAL. I PURCHASED THE PRODUCT ON (B)(6) AND I USED THE PRODUCT BETWEEN 8 AND 10 TIMES BOTH IN THE ACUTE AND PREVENTATIVE SETTINGS OVER THE COURSE OF THE NEXT 30 DAYS. I STARTED TO NOTICE I WAS EXPERIENCING FLUCTUATING BILATERAL EAR FULLNESS THAT WOULD LAST A FEW HOURS A DAY BUT CHALKED THAT UP TO SEASONAL ALLERGIES. THE EAR FULLNESS CONTINUED TO GET WORSE OVER TIME AT WHICH POINT I STOPPED USING THE CEFALY AS REGULARLY IN THE FIRST 2 WEEKS AFTER RECEIVING THE DEVICE. I ONLY USED IT 2 TIMES AFTER (B)(6), A 60-MINUTE SESSION ON (B)(6) AND A 20-MINUTE SESSION ON (B)(6). BY THE (B)(6), I STARTED TO NOTICE SEVERE BRAIN FOG, VISION SENSITIVITY AND WORSENING CONSTANT EAR FULLNESS THAT NEVER WENT AWAY. CEFALY'S MEDICAL TEAM CLAIMED I MAY HAVE PLACED THE DEVICE TOO CLOSE TO THE EYEBROWS DESPITE WHAT THEIR INSTRUCTIONAL VIDEOS SHOW WHICH MIGHT RESULT IN HIGHER STIMULATION TO A DENSE CONCENTRATION OF NERVES AS THEY EXIT THE HEAD. NOWHERE WAS IT EXPLAINED IN THE VIDEO OR PACKET THAT PLACING THE DEVICE 1/4 OF AN INCH TOO LOW COULD RESULT IN PERMANENT DAMAGE. NOW, 2 MONTHS LATER, (B)(6) IN MEDICAL BILLS, A BRAIN MRI AND CT AND NUMEROUS DOCTORS VISITS, I AM STILL DEALING WITH THESE PROBLEMS. THE FDA SHOULD PULL THE CEFALY OFF THE MARKET AND DEFINITELY NOT MAKE IT AVAILABLE WITHOUT A PRESCRIPTION UNTIL MORE EXTENSIVE RESEARCH HAS BEEN DONE. FDA SAFETY REPORT ID # (B)(4).