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

Health Effect - Clinical Code	Headache (1880)
Date of Event	06/16/2020
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: LIGHT, ULTRAVIOLET, DERMATOLOGICAL
• Manufacturer (Section D): DAMAN BEAUTY LLC ; 5252 hollister st ; ste 525; houston TX 77040
• MDR Report Key: 10189254
• Report Number: MW5095176
• Device Sequence Number: 988542
• Product Code: FTC
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 06/19/2020

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
• Operator of Device: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/23/2020
• Patient Sequence Number: 1