inforMED
InjuryPCC

CEFALY DUAL ENHANCED

Received Nov 15, 2021 · Event occurred Nov 5, 2021

Report MW5105353 · MDR key 12820685

Device

Generic name

Stimulator, Nerve, Electrical, Transcutaneous, For Migraine

Manufacturer

Cefaly Technology

Product problems

  • Charging Problem
  • Power Problem
  • Therapeutic or Diagnostic Output Failure

Patient

54 YR · Female

  • Electric Shock
  • Electric Shock

Narrative

Description of Event or Problem

WHILE DOING THE NINETY DAY TRAIL REPORTER WAS IN THE TWELFTH DAY OF USE WHEN SHE NOTICED THAT THE DEVICE WAS NOT CHARGING PROPERLY. SHE CONTINUED TO LET IT CHARGE AND ONCE SHE PUT THE DEVICE ON IT FELT EXTREMELY HOT. WHEN SHE TRIED TO USE THE POWER OFF BUTTON, THE DEVICE BEGAN SHOCKING HER FINGERS AND HANDS AS SHE TRIED TO REMOVE IT FROM HER HEAD. REPORTER CALLED CEFALY HELP DESK AND WAS TOLD THERE WAS NO ONE AVAILABLE TO HELP HER AND SHE WOULD NEED TO WAIT TWENTY-FOUR TO FORTY-EIGHT HOURS BEFORE SOMEONE COULD RETURN HER CALL. REPORTER WAITED SEVERAL DAYS TO HEAR BACK FROM CEFALY AND WHEN SHE DID IT WAS VIA EMAIL. THE REPORTER THEN CONTACTED THE CEFALY AND THE REPRESENTATIVE TOLD HER THAT THEY WOULD SEND HER A NEW ONE. THE REPORTER DID NOT FEEL COMFORTABLE RECEIVING A NEW ONE WITHOUT CEFALY BEING ABLE TO TELL HER HOW AND WHY HER DEVICE MALFUNCTIONED THE WAY IT DID. THE REPORTER WILL SEND HER DEVICE BACK TO CEFALY.