MAUDE Adverse Event Report: DAMAN BEAUTY LLC LED COLOR LIGHT MASK / APHRONA BEAUTY; LIGHT, ULTRAVIOLET, DERMATOLOGICAL

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

Patient Problem Headache (1880)

Event Date 06/16/2020

Event Type  malfunction  

Event Description

Bought an aphrona brand led face mask for home use because it advertised that is fda approved, can not find any information that this is true.Having some headaches since starting home treatment, i have stopped use of the device for meantime and will see my physician.Fda safety report id # (b)(4).

• Brand Name: LED COLOR LIGHT MASK / APHRONA BEAUTY
• Type of Device: LIGHT, ULTRAVIOLET, DERMATOLOGICAL
• Manufacturer (Section D): DAMAN BEAUTY LLC ; 5252 hollister st ; ste 525; houston TX 77040
• MDR Report Key: 10189254
• MDR Text Key: 196467214
• Report Number: MW5095176
• Device Sequence Number: 1
• Product Code: FTC
• 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: 06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1