MAUDE Adverse Event Report: CEFALY TECHNOLOGY CEFALY; CEFALY ENHANCED

Model Number	10603
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
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.
Event or Problem Description
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.

• Brand Name: CEFALY
• Common Device Name: CEFALY ENHANCED
• Manufacturer (Section D): CEFALY TECHNOLOGY; rue louis plescia 34,; 4102; seraing 4102 ; BE 4102
• MDR Report Key: 19061975
• Report Number: 3010760764-2024-00002
• Device Sequence Number: 6592466
• Product Code: PCC
• UDI-Device Identifier: 05425018850273
• UDI-Public: (01)05425018850273(17)240227
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/08/2024
• Report Date (Section F): 04/07/2024

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: 02/27/2024
• Device Model Number: 10603
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Home
• Date Report to Manufacturer: 04/07/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/08/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Date Report Sent to FDA: 04/07/2024