MAUDE Adverse Event Report: CEFALY TECHNOLOGIES CEFALY PREVENT; STIMULATOR, NERVE, ELECTRICAL, TRANSCUTANEOUS, FOR MIGRAINE

Device Problem Thermal Decomposition of Device (1071)

Patient Problems Headache (1880); Pain (1994); Blurred Vision (2137); Burn, Thermal (2530)

Event Date 04/13/2019

Event Type  Injury  

Event Description

I was using the cefaly device with a new electrode, as i normally do.The electrode was placed in the proper position on my forehead, and approx 5 mins into the session the device malfunctioned and began electrocuting my forehead where the electrode was placed.The device electrocuted and burned me, and left my vision blurred for about an hour and terrible pain behind my eyes.The unit actually physically burned all the way through the electrode.I use the cefaly unit for migraines and this event has triggered a migraine that has been persistent since the event.I am waiting to get into see my pcp to get evaluated further.Since the event, the mfr has tried to convince me to reuse the malfunctioning unit, and is now preventing my access to this medical treatment to which i have a prescription.This company seems to be suspect as all the employees that work in the usa say they cannot do anything without approval from (b)(4) and infuse to give me the direct contact info for the "supervisor" in (b)(4).I have a picture of the product.Fda safety report id# (b)(4).

• Brand Name: CEFALY PREVENT
• Type of Device: STIMULATOR, NERVE, ELECTRICAL, TRANSCUTANEOUS, FOR MIGRAINE
• Manufacturer (Section D): CEFALY TECHNOLOGIES
• MDR Report Key: 8555743
• MDR Text Key: 143419297
• Report Number: MW5086211
• Device Sequence Number: 1
• Product Code: PCC
• Combination Product (y/n): N
• 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: 04/24/2019

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: 04/25/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Disability
• Patient Age: 32 YR
• Patient Weight: 93