CEFALY PREVENT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-25 for CEFALY PREVENT manufactured by Cefaly Technologies.

Event Text Entries

[143419297] 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).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5086211
• MDR Report Key: 8555743
• Date Received: 2019-04-25
• Date of Report: 2019-04-24
• Date of Event: 2019-04-13
• Date Added to Maude: 2019-04-26
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: CEFALY PREVENT
• Generic Name: STIMULATOR, NERVE, ELECTRICAL, TRANSCUTANEOUS, FOR MIGRAINE
• Product Code: PCC
• Date Received: 2019-04-25
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CEFALY TECHNOLOGIES

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening; 2. Deathisabilit	2019-04-25