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

Model Number 10530

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Tingling (2171); Dysphasia (2195); Reaction (2414); Numbness (2415)

Event Date 02/27/2021

Event Type  Injury  

Event Description

Loss of control of eyes; i used the ceflay device for migraines.First, my eyes started to tingle, later i could not open my eyes without extreme pain, the top of my head was numb to the touch like when you go to the dentist but painful like i was being scalped.I took a video of me trying to use it for 20 minutes to prevent migraines and only made it ten minutes due to the amount of pain it caused.When i did turn it off the pain instantly went away but it took a little while for my eye site to return to normal.I feel like my vegas nerve is still mad at me 24 hours later and is sore to the touch.If you look at the video, you can see me complete change in how i feel, and a friend commented it looked like i was having a stroke as i struggled to talk.This device needs to come with a warning.I found out later i could have kept the device from ramping up to as high of a level, but it also says if you stop it from ramping you don't get the full therapy amount.Heck with that.Feel free to let me know if you want to see the video.My neck and head have tenderness they did not have before i tried the device.The package shows happy women wearing the device, i had no idea it would cause so much pain, my not being able to keep my eyes open, and weird numbness in my head.I understand it helps some people, but i would like better warnings on the package that it might not be safe for everyone.I would like to see better warnings on the package.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: 11404442
• MDR Text Key: 234940356
• Report Number: MW5099755
• Device Sequence Number: 1
• Product Code: PCC
• 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: 03/01/2021

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
• Device Model Number: 10530
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/02/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 75