MAUDE Adverse Event Report: CEFALY TECHNOLOGY CEFALY; CEFALY CONNECTED

Model Number	10804
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
This incident occurred in canada.There is no evidence indicating that it meets the criteria for a reportable medical device incident.The reporting is conducted based on the precautionary principle.Date of incident: exact date not yet confirmed; the incident occurred prior to (b)(6) 2026.Description of the event: according to the customer report: the user completed a 20-minute treatment session using the device.No abnormalities were observed during the treatment session.Approximately 10 minutes after completing the treatment, the device was placed on the charging dock.The device appeared to begin charging normally.After approximately 45-60 minutes of charging, the customer reported hearing a "pop" sound originating from the device followed by the detection of an odor of burning plastic.Device use information: based on the information provided by the customer: the original usb cable supplied with the device was used.The device had not previously become warm or overheated during charging.The device was connected to the same electrical outlet normally used for charging.The customer reported that the adaptor used was the original adaptor provided with the device.However, cefaly devices are sold without a power adaptor.Based on photographs provided by the customer, the adaptor used does not appear to be manufactured by cefaly and does not appear to meet the charging specifications described in the user manual.The device had reportedly been charged using the same accessories since (b)(6) 2025.The customer was requested to return the device, along with the adaptor, cable, and charging dock used, for investigation.As of the reporting date, the items have not been received.

• Brand Name: CEFALY
• Common Device Name: CEFALY CONNECTED
• Manufacturer (Section D): CEFALY TECHNOLOGY; légiapark,; boulevard patience et beaujonc; bte28, liege, 4000 ; BE 4000
• MDR Report Key: 24783799
• Report Number: 3010760764-2026-00003
• Device Sequence Number: 10036622
• Product Code: PCC
• UDI-Device Identifier: 05425018850297
• UDI-Public: (01)05425018850297(17)261114
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/03/2026
• Report Date (Section F): 04/03/2026

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
• Operator of Device: Lay User/Patient
• Device Model Number: 10804
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/05/2026
• Event Location: Home
• Date Report to Manufacturer: 03/05/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/03/2026