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

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

Patient Problems Burn, Thermal (2530); Skin Burning Sensation (4540)

Event Date 01/15/2021

Event Type  Injury  

Event Description

Burned my skin on face; i bought a uv lamp from the link www.Amazon.Com/dp/b06xcggj7c to treat my psoriasis.I used this lamp 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
• MDR Report Key: 11236804
• MDR Text Key: 229598942
• Report Number: MW5099035
• 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: 01/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/26/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Required Intervention; Disability