MAUDE Adverse Event Report: CEFALY USA CEFALY

Device Problem Human Factors Issue (2948)

Patient Problems Headache (1880); Pain (1994); Reaction (2414)

Event Date 01/16/2016

Event Type  Injury  

Event Description

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.

• Brand Name: CEFALY
• Type of Device: CEFALY
• Manufacturer (Section D): CEFALY USA
• MDR Report Key: 5808340
• MDR Text Key: 50081181
• Report Number: MW5063519
• 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: 07/15/2016

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/03/2017
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/15/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 73