MAUDE Adverse Event Report: CEFALY TECHNOLOGY CEFALY DUAL; STIMULATOR, NERVE, ELECTRICAL, TRANSCUTANEOUS, FOR MIGRAINE

Device Problem Wireless Communication Problem (3283)

Patient Problem Blurred Vision (2137)

Event Date 12/09/2020

Event Type  Injury  

Event Description

I use a cefaly dual migraine device for migraines and i think it picks up wifi (or similar signals) and damages the eyes as one of my eyes kept getting blurry vision which then clears up in a day or two.I then cancelled wifi and went back to ethernet and the problem has not repeated.I'm a long-time cefaly user since around 2015.I had the first version which is like a crown on the forehead and then got the smaller version when it came out.In sum, i support cefaly and can't go without using it, but i now ration the usage on the dual by only using the 20-minute setting.The original crown version was limited to 20 minutes at a time.When cefaly went to a 60-minute setting on their current versions, i think this made it dangerous.Overall, i think the fda should really investigate these (head or brain-mounted) wireless-type battery-powered devices that emit sound waves as they seem to be capable of picking up extraneous signals.I'm not kidding - i have used the cefaly for 7 years now almost daily and i have extensive knowledge of how it works and the results.I also have the rear arnold strap and that works pretty well also.Please look into it.Thank you for listening to my story.Fda safety report id # (b)(4).

• Brand Name: CEFALY DUAL
• Type of Device: STIMULATOR, NERVE, ELECTRICAL, TRANSCUTANEOUS, FOR MIGRAINE
• Manufacturer (Section D): CEFALY TECHNOLOGY
• MDR Report Key: 11453430
• MDR Text Key: 239137207
• Report Number: MW5099890
• Device Sequence Number: 1
• Product Code: PCC
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/09/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 102