MAUDE Adverse Event Report: UNKNOWN OMNILUX CONTOUR FACE; LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION

Device Problem Use of Device Problem (1670)

Patient Problem Skin Discoloration (2074)

Event Date 11/01/2022

Event Type  Injury  

Event Description

Reporter called to report skin pigmentation from using contour face mask by omnilux.

• Brand Name: OMNILUX CONTOUR FACE
• Type of Device: LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 16984507
• MDR Text Key: 315855688
• Report Number: MW5117775
• Device Sequence Number: 1
• Product Code: OHS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Sex: Female