MAUDE Adverse Event Report: CEFALY TECHNOLOGY CEFALY

Lot Number 6SB45 14073 D4.23

Device Problem Insufficient Information (3190)

Patient Problem Headache (1880)

Event Date 08/01/2014

Event Type  Injury  

Event Description

I purchased a cefaly medical device prescribed by my neurologist to help decrease the frequency of the headaches which i have suffered with for many years.U.S.Patent # 8,428,734.

• Brand Name: CEFALY
• Type of Device: CEFALY
• Manufacturer (Section D): CEFALY TECHNOLOGY; herstal ; BE
• MDR Report Key: 4201657
• MDR Text Key: 5036585
• Report Number: MW5038794
• 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: 10/11/2014

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 Lot Number: 6SB45 14073 D4.23
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/24/2014
• Patient Sequence Number: 1
• Treatment: SYNTHROID DAILY
• Patient Age: 59 YR
• Patient Weight: 84