MAUDE Adverse Event Report: CEFALY TECHNOLOGY CEFALY; CEFALY ENHANCED

Model Number	10601
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
This document is a preliminary report based on the information currently available, prepared with careful consideration.At this time, there is no evidence indicating that the issue is due to a malfunction of the cefaly product.The device has been returned by the customer and is now on its way to the factory for a thorough investigation.A detailed update will be provided after the device has been closely examined.The customer reported that they discovered the device was melted overnight while charging.Customer said last used the device last week of the incident and at that time the device were fine.
Additional Manufacturer Narrative
The team has sent the device to the factory for analysis.Efforts are also underway to reach out to the user to gather the patient's details as outlined in section a.It's important to note that the age and weight information we have now is estimated and will be confirmed directly with the patient.Please note that this information may be updated.

• Brand Name: CEFALY
• Common Device Name: CEFALY ENHANCED
• Manufacturer (Section D): CEFALY TECHNOLOGY; rue louis plescia 34,; 4102; seraing 4102 ; BE 4102
• Manufacturer (Section G): JDI ELECTRONICS FACTORY; sima industrial district; sima village, chang ping town; dongguan, guangdong 52357 0; CH 523570
• Manufacturer Contact: stephen chan ; rue louis plescia 34,; seraing, 4102 ; BE 4102
• MDR Report Key: 19061980
• Report Number: 3010188009-2024-00002
• Device Sequence Number: 12410394
• Product Code: PCC
• UDI-Device Identifier: 05425018850273
• UDI-Public: (01)05425018850273(17)240207
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K201895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/08/2024

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 Expiration Date: 02/07/2024
• Device Model Number: 10601
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 04/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 50 KG