MAUDE Adverse Event Report: CEFALY TECHNOLOGY CEFALY; CEFALY DUAL

Model Number 10530

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems Headache (1880); Visual Impairment (2138); Dizziness (2194); Cognitive Changes (2551); Unspecified Ear or Labyrinth Problem (4474)

Event Date 06/07/2021

Event Type  Injury  

Manufacturer Narrative

The patient initially contact the company regarding a feeling of ear fullness, indicating placement of the electrode lower than shown in the manual.In additional contacts by the company to gain more information, the patient later indicated ear pain, dizziness, vestibular migraines, noise sensitivity, and slight vision sensitivity, in some cases asking if these could have been caused by the device.There was no indication that these were persistent, permanent, or required medial intervention.These were evaluated and considered a non-reportable adverse event.The device was returned and evaluated, and was functioning within specifications.The patient reported to the fda ear fullness that never went away, severe brain fog, and vision sensitivity in mw5102802, as well as multiple doctor visits and mri and ct scans, which had not been reported to cefaly.Cefaly has attempted additional contact with the patient for additional information both to better understand the event, especially those symptoms that had not been reported to the company.We made four attempts, on separate dates and times, using two forms of communication (email and phone) to contact the patient for additional information.At this time, no additional information is available.Given the currently available information, cefaly is not able to preclude the possibility that the device caused or contributed to this adverse event.Cefaly is not able to preclude the possibility that the event might meet the definition of a serious adverse event, and it is not clear if any of the symptoms might be permanent or require medical intervention to preclude permanent impairment or damage.Therefore, we are reporting this event out of an abundance of caution.Our information is limited and incomplete, and additional information will be submitted if and when available.

Event Description

Patient describes ear fullness, ear pain, dizziness, vestibular migraines, noise sensitivity, vision sensitivity, and brain fog, having used the product 8-10 times in 30 days.

• Brand Name: CEFALY
• Type of Device: CEFALY DUAL
• Manufacturer (Section D): CEFALY TECHNOLOGY; rue louis plescia 34; 4102 seraing; seraing, liege 4102 ; BE 4102
• Manufacturer (Section G): CEFALY TECHNOLOGY; rue louis plescia 34; seraing, liege 4102 ; BE 4102
• Manufacturer Contact: michael johnson ; 19 old kings hwy s,; darien, CT 06820
• MDR Report Key: 12476427
• MDR Text Key: 271718566
• Report Number: 3010188009-2021-00001
• Device Sequence Number: 1
• Product Code: PCC
• UDI-Device Identifier: 5425018850259
• UDI-Public: (01)5425018850259(17)230508
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/15/2021

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/08/2023
• Device Model Number: 10530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Initial Date Manufacturer Received: 06/28/2021
• Initial Date FDA Received: 09/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other