MAUDE Adverse Event Report: CEFALY TECHNOLOGY CEFALY; STIMULATOR, NERVE, ELECTRICAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reaction (2414)

Event Type  malfunction  

Event Description

Reports use of cefaly device with good result for several months, but then developed skin reaction across forehead from electrode gel.Resolved with triamcinolone rx by derm.Recurrence with use, despite hypoallergenic gel.Dates of use: (b)(6) 2017.(b)(4).

• Brand Name: CEFALY
• Type of Device: STIMULATOR, NERVE, ELECTRICAL
• Manufacturer (Section D): CEFALY TECHNOLOGY; rue louis plescia, 34; seraing 4102 ; BE 4102
• MDR Report Key: 7150597
• MDR Text Key: 96054491
• Report Number: MW5074265
• 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: Physician
• Type of Report: Initial
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Weight: 61