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

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

Patient Problems Irritation (1941); Burn, Thermal (2530)

Event Date 01/15/2021

Event Type  Injury  

Event Description

My skin burned and got worse; www.Amazon.Com/dp/b06xcggj7c.I bought a uv phototherapy lamp from this link from amazon.My skin 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 PHOTOTHERAPY
• Type of Device: LIGHT, ULTRAVIOLET, DERMATOLOGICAL
• MDR Report Key: 11236789
• MDR Text Key: 229592472
• Report Number: MW5099034
• 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: 01/22/2021

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: Lay User/Patient
• 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): Hospitalization; Life Threatening; Other; Required Intervention; Disability