inforMED
InjuryPCC

CEFALY

Received Nov 8, 2024

Report MW5162339 · MDR key 20664124

Device

Generic name

Stimulator, Nerve, Electrical, Transcutaneous, For Migraine

Manufacturer

Cefaly Technology

Patient

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).