MAUDE Adverse Event Report: CEFALY TECHNOLOGY CEFALY; CEFALY ENHANCED

Model Number 10601

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 03/08/2024

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 340464927
• Report Number: 3010188009-2024-00002
• Device Sequence Number: 1
• Product Code: PCC
• UDI-Device Identifier: 05425018850273
• UDI-Public: (01)05425018850273(17)240207
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/07/2024
• Device Model Number: 10601
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/28/2023
• Initial Date FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/30/2021
• 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
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 50 KG