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

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

Patient Problem Burn, Thermal (2530)

Event Date 01/21/2021

Event Type  Injury  

Event Description

It burned skin terribly; 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 PHOTOTHERAPHY
• Type of Device: LIGHT, ULTRAVIOLET, DERMATOLOGICAL
• Manufacturer (Section D): ANGEL KISS LLC
• MDR Report Key: 11272413
• MDR Text Key: 230327986
• Report Number: MW5099157
• 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: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• 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): Other