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

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

Patient Problems Skin Irritation (2076); Burn, Thermal (2530)

Event Date 01/15/2021

Event Type  Injury  

Event Description

(b)(6).I bought a uv phototherapy lamp from this link from (b)(6).My skin was burned and got worse after applying this.Tried again the next day to see if maybe it was just a fluke, burned even worse and irritated the skin more than it already was.Fda should require (b)(6) to remove this item from its website.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: 11272493
• MDR Text Key: 230328049
• Report Number: MW5099162
• 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: 01/30/2021

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): Hospitalization; Life Threatening; Other; Required Intervention; Disability