MAUDE Adverse Event Report: XUZHOU KERNEL MEDICAL INSTRUMENT EQUIPMENT CO LTD KN-4003 UV PHOTOTHERAPY; LIGHT, ULTRAVIOLET, DERMATOLOGICAL

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

Patient Problem Radiation Burn (1755)

Event Date 01/16/2021

Event Type  Injury  

Event Description

I am a patient suffering from psoriasis for 2 years.I was badly burned after using a uv phototherapy lamp on (b)(4).The manual clearly indicates that this lamp is a prescription (rx) medical device.It will cause severe burning to people if they do not use this psoriasis lamp under the direction of a licensed doctor.However, it is now still available on (b)(4) and burned people like me who bought it.This obviously violates fda regulations.The link of the product i bought on (b)(4).Fda should look into this immediately to avoid more burning from patient like me.Fda must require (b)(4) to remove this item.

• Brand Name: KN-4003 UV PHOTOTHERAPY
• Type of Device: LIGHT, ULTRAVIOLET, DERMATOLOGICAL
• Manufacturer (Section D): XUZHOU KERNEL MEDICAL INSTRUMENT EQUIPMENT CO LTD
• MDR Report Key: 11207545
• MDR Text Key: 228454713
• Report Number: MW5098927
• 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
• Type of Report: Initial
• Report Date: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Disability