MAUDE Adverse Event Report: CEFALY TECHNOLOGY CEFALY; TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR TO TREAT HEADACHE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Type  Other  

Event Description

Helped with patient's symptoms in past, may no longer help reported by hcp reporter didn't consent to followup (b)(6).

• Brand Name: CEFALY
• Type of Device: TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR TO TREAT HEADACHE
• Manufacturer (Section D): CEFALY TECHNOLOGY
• MDR Report Key: 17086180
• MDR Text Key: 316861611
• Report Number: MW5118260
• Device Sequence Number: 1
• Product Code: PCC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 06/05/2023

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/07/2023
• Patient Sequence Number: 1