MAUDE Adverse Event Report: CEFALY TECHNOLOGY CEFALY ; STIMULATOR, NERVE, ELECTRICAL, TRANSCUTANEOUS, FOR MIGRAINE

Model Number

Device Problem Product Quality Problem (1506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/27/2019

Event Type  malfunction  

Event Description

Unable to treat migraine; i purchase the cefaly in 2018.It fell apart in 2019 rendering it inoperable to provide relief for my migraines.The product is expensive, (b)(6).The product should not fall apart after normal use.Fda safety report id# (b)(4).

• Brand Name: CEFALY
• Type of Device: STIMULATOR, NERVE, ELECTRICAL, TRANSCUTANEOUS, FOR MIGRAINE
• Manufacturer (Section D): CEFALY TECHNOLOGY
• MDR Report Key: 9671457
• MDR Text Key: 178025743
• Report Number: MW5092757
• Device Sequence Number: 1
• Product Code: PCC
• 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
• Type of Report: Initial
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/18/2021

Device Model Number

• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/04/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 113