CEFALY

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-15 for CEFALY manufactured by Cefaly Usa.

Event Text Entries

[50081181] I purchased a new cefaly device through a prescription. I was given the prescription due to periodic headaches. I was not given suggestions or instructions by my doctor. When i received the device i read the included instruction booklet. The booklet stated in the instructions that it is not effective at full strength. Therefore, i used the item twice at the full strength program twice over two days. When the device was on, it felt like my head was being drilled. In addition, i was not able to keep my eyes open during the program as the pulses were too strong. During the next 3-4 days, i had severe headaches that made it so i was unable to read or focus on work. I also had consistent pain in the brow region of my forehead where the cefaly pad attached. The pain and severe headache then decreased. However, for the past 6 months, i have woken up with a headache every single day (when i only had headaches periodically before). In addition, i am more sensitive to bright lights and an only able to work at computers for a short amount of hours before i get a pounding headache on the right side of my scalp above my ear. Also, i have a continuously pulsating facial muscle below my left eye that won't seem to stop. In short the device has negatively impacted my quality of life. One thing that definitely needs to change is the instruction manual. It says that the device is most effective used at full strength and doesn't clearly explain the stabilization feature. This feature allows the pulses to be controlled so that they stop increasing and remain at a constant level. If i had clearly understood this feature, i would have used it so that the pulses never reached the intolerable full strength. I wrote the mfr about this and they stated that they would "let the r&d team know the comments and talk to the team about adding more explanations in the user manual. " i hope that changes are made so that pts do not needlessly suffer from using this device at full strength. The moral here is that medical devices aren't any safer than prescription drugs. They too can have side effects.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5063519
• MDR Report Key: 5808340
• Date Received: 2016-07-15
• Date of Report: 2016-07-15
• Date of Event: 2016-01-16
• Date Added to Maude: 2016-07-20
• 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
• Generic Name: CEFALY
• Product Code: PCC
• Date Received: 2016-07-15
• Device Expiration Date: 2017-07-03
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CEFALY USA

Patients

Patient Number	Treatment	Outcome	Date
1	0		2016-07-15