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

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

Patient Problem Burning Sensation (2146)

Event Date 01/18/2021

Event Type  Injury  

Event Description

I bought a uv lamp from the link (b)(6) to treat my psoriasis.I put this on my face and then 30 seconds go by and my face felt like it was burning off, even after washing my face i couldn't get it to stop burning.This device is a prescription (rx) medical device which shows in its package and manual.It is illegal to sell this psoriasis lamp online without doctor's prescription according to fda regulations.It will cause severe burning to people if they do not use this psoriasis lamp under the direction of a licensed physician.Fda should remove this device from (b)(6).Fda safety report id# (b)(4).

• Brand Name: UV PHOTOTHERAPY LAMP
• Type of Device: LIGHT, ULTRAVIOLET, DERMATOLOGICAL
• Manufacturer (Section D): XUZHOU KERNEL MEDICAL INSTRUMENT EQUIPMENT CO LTD
• MDR Report Key: 11236344
• MDR Text Key: 229153395
• Report Number: MW5099017
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability