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

Model Number KN-4003BL

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

Patient Problems Hemorrhage/Bleeding (1888); Eczema (4547)

Event Date 01/30/2021

Event Type  Injury  

Event Description

Terrible product.After just one use, my husband's eczema got much worse.We weren't sure if it was the reaction or not, so he kept using it for a few more days.And his eczema not only got worse than it had ever been before, it began to crack and bleed so badly he had to go to urgent care because we were afraid, he might get an infection.The picture shown is after 3 uses.The lamp came from (b)(4).

• Brand Name: UV PHOTOTHERAPY LAMP
• Type of Device: LIGHT, ULTRAVIOLET, DERMATOLOGICAL
• Manufacturer (Section D): ANGEL KISS LLC
• MDR Report Key: 11292994
• MDR Text Key: 230995256
• Report Number: MW5099268
• Device Sequence Number: 1
• Product Code: FTC
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• 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; Required Intervention; Disability