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  

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; seraing, liege 4102 ; BE 4102
• MDR Report Key: 12477525
• MDR Text Key: 271570721
• Report Number: 3010760764-2021-00084
• 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
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/15/2021
• Distributor Facility Aware Date: 08/16/2021
• Event Location: Home
• Date Report to Manufacturer: 08/16/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other