MAUDE Adverse Event Report: CEFALY TECHNOLOGY CEFALY; CEFALY ENHANCED

Model Number 10603

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 11/01/2023

Event Type  malfunction  

Event Description

This document serves as a preliminary report, compiled with the information presently available and adhering to the principle of caution.Currently, there is no evidence to suggest that the issue is attributable to a malfunction of the cefaly product.The device in question has been returned by the customer and is presently en route to the factory for in-depth analysis.A comprehensive update will be issued following a detailed examination of the device.As per the information provided by the customer, the incident occurred a few weeks prior to their report on november 28, 2023.However, the customer has not specify the exact date of the incident.Consequently, the date recorded in section b3 is an estimated one.The customer reported that they discovered the plastic housing of the cefaly device partially melted on the charging dock during the charging process.It was noted that the device had been charging for approximately four hours prior to the incident.It is important to highlight that the charging dock was connected to an adapter provided by the client, which is not a product of cefaly.Furthermore, the customer indicated that although the device had not been heavily used in the past, there had been an increase in both usage and frequency of charging in the period leading up to the incident.

Manufacturer Narrative

The team has dispatched the device to the factory for analysis.Additionally, efforts are being made to contact the user to obtain the patient's information in section a.It should be noted that the age and weight details currently available are estimated and will be verified with the patient directly.Please be aware that this information is subject to change.

• 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: 18417424
• MDR Text Key: 331599065
• Report Number: 3010188009-2023-00001
• Device Sequence Number: 1
• Product Code: PCC
• UDI-Device Identifier: 05425018850273
• UDI-Public: (01)05425018850273(17)240129
• 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: 12/28/2023

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: 01/29/2024
• Device Model Number: 10603
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/28/2023
• Initial Date FDA Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: 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 Weight: 50 KG