MAUDE Adverse Event Report: ANGEL KISS LLC. UV PHOTOTHERAPY LAMP; LIGHT, ULTRAVIOLET, DERMATOLOGICAL

Model Number KN-4003BL

Device Problems Use of Device Problem (1670); Patient-Device Incompatibility (2682)

Patient Problem Burn, Thermal (2530)

Event Date 01/27/2021

Event Type  Injury  

Event Description

I had a minor flare up around my eyebrows and my nose so i figured i'd give this a try.This is what my face looks like after 3 days of use of this uv lamp twice per day.My face got deadly burned.It is horrible and led me to hospital.This is a prescription (rx) medical device for skin disorders and should not be available on (b)(6) without prescription.Source of this lamp: (b)(6).Fda safety report id# (b)(4).

• Brand Name: UV PHOTOTHERAPY LAMP
• Type of Device: LIGHT, ULTRAVIOLET, DERMATOLOGICAL
• Manufacturer (Section D): ANGEL KISS LLC.
• MDR Report Key: 11285503
• MDR Text Key: 230743688
• Report Number: MW5099240
• Device Sequence Number: 1
• Product Code: FTC
• 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: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: KN-4003BL
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Disability
• Patient Age: 19 YR