MAUDE Adverse Event Report: CEFALY TECHNOLOGY CEFALY DUAL MEDICAL DEVICE FOR MIGRAINE SUFFERERS; STIMULATOR, NERVE, ELECTRICAL, TRANSCUTANEOUS, FOR MIGRAINE

Model Number IP22

Device Problem Product Quality Problem (1506)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/02/2021

Event Type  Injury  

Event Description

I purchased a cefaly dual medical device for migraine suffers for my (b)(6) year old niece on (b)(6) 2022.She used it for about 2 months, 4 or 5 times a week.She started having olfactory hallucinations of cigarette smoke or burning electrical wiring.On or about (b)(6) 2021, i contacted cefaly technology customer service to see if there was any correlation to the use on the cefaly device and these olfactory hallucinations.The next day, a customer service representative contacted my niece and told her to discontinue using it, as there have been other reports involving olfactory hallucinations.This device is advertised as the only fda approved device for treatment of migraines.Fda safety report id # (b)(4).

• Brand Name: CEFALY DUAL MEDICAL DEVICE FOR MIGRAINE SUFFERERS
• Type of Device: STIMULATOR, NERVE, ELECTRICAL, TRANSCUTANEOUS, FOR MIGRAINE
• Manufacturer (Section D): CEFALY TECHNOLOGY
• MDR Report Key: 12835688
• MDR Text Key: 281028941
• Report Number: MW5105434
• Device Sequence Number: 1
• Product Code: PCC
• UDI-Device Identifier: 05425018850259
• UDI-Public: 0105425018850259
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 11/16/2021

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
• Device Model Number: IP22
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/17/2021
• Patient Sequence Number: 1
• Treatment: EXCEDRINE HEADACHE FORMULA; MAGNESIUM
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 84 KG
• Patient Ethnicity: Hispanic
• Patient Race: White