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

Model Number	IP22
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/02/2021
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: STIMULATOR, NERVE, ELECTRICAL, TRANSCUTANEOUS, FOR MIGRAINE
• Manufacturer (Section D): CEFALY TECHNOLOGY
• MDR Report Key: 12835688
• Report Number: MW5105434
• Device Sequence Number: 4351758
• Product Code: PCC
• UDI-Device Identifier: 05425018850259
• UDI-Public: 0105425018850259
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Lay User/Patient
• Device Model Number: IP22
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/17/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXCEDRINE HEADACHE FORMULA; MAGNESIUM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 84 KG
• Patient Ethnicity: Hispanic
• Patient Race: White