STIMULATOR, NERVE, ELECTRICAL, TRANSCUTANEOUS, FOR MIGRAINE

Description of Event or Problem

DURING THE CALL PATIENT SAID: THEY USED THEIR CEFALY ONE TIME IN THE PAST AND IT WAS SO STRONG THEY THOUGHT IT WAS GOING TO BURN A HOLE IN THEIR FOREHEAD, THEY WERE TOLD TO TURN IT DOWN BUT COULDN'T FIGURE OUT HOW TO DO THAT, PATIENT DID NOT CONTINUE USING IT. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).