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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Radiation Burn (1755)

Event Date 01/21/2021

Event Type  Injury  

Event Description

I ordered a uv phototherapy lamp from (b)(6).I tried it twice, the first time it burned terribly but i thought it might be helping but couldn't handle the burn so i stopped it.Today i put it on again it burned and spread, my skin is the worse its ever been now.This is a prescription (rx) medical device and should not be available on (b)(6) without prescription.Otherwise, patients will get burned like me.Fda safety report id# (b)(4).

• Brand Name: UV PHOTOTHERAPY
• Type of Device: LIGHT, ULTRAVIOLET, DERMATOLOGICAL
• MDR Report Key: 11243774
• MDR Text Key: 229873543
• Report Number: MW5099071
• Device Sequence Number: 1
• Product Code: FTC
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• 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): Life Threatening; Other; Required Intervention