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

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 04/14/2017

Event Type  Injury  

Event Description

On (b)(6) 2017, day one - i received the device and charged it.The next day, day two on (b)(6) 2017, i used it for the recommended 20 minutes reducing the intensity.The following day - day 3 on (b)(6) 2017, i used it for the recommended 20 minutes.The ringing in my ears increased.It has not gone away, was a low volume.Now it is a medium volume.

• Brand Name: CEFALY II
• Type of Device: STIMULATOR, NERVE, ELECTRICAL, TRANSCUTANEOUS FOR MIGRAINE
• Manufacturer (Section D): CEFALY TECHNOLOGY ; BE
• MDR Report Key: 6593589
• MDR Text Key: 76148009
• Report Number: MW5070032
• 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: 05/17/2017

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/24/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Weight: 57