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

Device Problems Charging Problem (2892); Power Problem (3010); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Electric Shock (2554)

Event Date 11/05/2021

Event Type  Injury  

Event Description

While doing the ninety day trail reporter was in the twelfth day of use when she noticed that the device was not charging properly.She continued to let it charge and once she put the device on it felt extremely hot.When she tried to use the power off button, the device began shocking her fingers and hands as she tried to remove it from her head.Reporter called cefaly help desk and was told there was no one available to help her and she would need to wait twenty-four to forty-eight hours before someone could return her call.Reporter waited several days to hear back from cefaly and when she did it was via email.The reporter then contacted the cefaly and the representative told her that they would send her a new one.The reporter did not feel comfortable receiving a new one without cefaly being able to tell her how and why her device malfunctioned the way it did.The reporter will send her device back to cefaly.

• Brand Name: CEFALY DUAL ENHANCED
• Type of Device: STIMULATOR, NERVE, ELECTRICAL, TRANSCUTANEOUS, FOR MIGRAINE
• Manufacturer (Section D): CEFALY TECHNOLOGY
• MDR Report Key: 12820685
• MDR Text Key: 280936088
• Report Number: MW5105353
• 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: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Sex: Female