inforMED
InjuryPCC

CEFALY

Received Sep 15, 2021 · Event occurred Jun 7, 2021

Report 3010760764-2021-00084 · MDR key 12477525

Device

Generic name

Cefaly Dual

Manufacturer

Cefaly Technology

Model number

10530

Product problems

  • Activation, Positioning or Separation Problem
  • Activation, Positioning or Separation Problem

Patient

Not reported

  • Headache
  • Visual Impairment
  • Dizziness
  • Cognitive Changes
  • Unspecified Ear or Labyrinth Problem
  • Headache
  • Visual Impairment
  • Dizziness
  • Cognitive Changes
  • Unspecified Ear or Labyrinth Problem

Narrative

Description of Event or Problem

PATIENT DESCRIBES EAR FULLNESS, EAR PAIN, DIZZINESS, VESTIBULAR MIGRAINES, NOISE SENSITIVITY, VISION SENSITIVITY, AND BRAIN FOG, HAVING USED THE PRODUCT 8-10 TIMES IN 30 DAYS.