InjuryPCC
CEFALY
Received Nov 8, 2024
Report MW5162339 · MDR key 20664124
Device
Generic name
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Manufacturer
Cefaly TechnologyPatient
NA · Unknown
- Device Overstimulation of Tissue
- Pain
- Device Overstimulation of Tissue
- Pain
Narrative
Description of Event or Problem
PATIENT MENTIONED THEY TRIED A DEVICE CALLED CEFALY IN THE PAST AND REPORTED EVERY TIME THEY TRIED TO USE IT THE ELECTRICAL STIMULATION HURT SO BAD IN BETWEEN THEIR EYEBROWS THAT THEY COULDN'T USE IT. PATIENT STATED SOME PEOPLE CAN USE IT AND SOME CAN'T. PATIENT STATED IT JUST DIDN'T WORK FOR THEM BUT SOME PEOPLE HAVE WONDERFUL RESULTS WITH IT. DISCLAIMER STATEMENT: THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).