MAUDE Adverse Event Report: CEFALY TECHNOLOGY CEFALY; CEFALY ENHANCED

Model Number 10603

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 03/08/2024

Event Type  malfunction  

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 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
• Type of Device: CEFALY ENHANCED
• Manufacturer (Section D): CEFALY TECHNOLOGY; rue louis plescia 34,; 4102; seraing 4102 ; BE 4102
• MDR Report Key: 19061975
• MDR Text Key: 339682203
• Report Number: 3010760764-2024-00002
• Device Sequence Number: 1
• Product Code: PCC
• UDI-Device Identifier: 05425018850273
• UDI-Public: (01)05425018850273(17)240227
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/07/2024,03/08/2024

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