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

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

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

Event Date 01/15/2021

Event Type  Injury  

Event Description

Burned my skin badly; (b)(6).I bought a uv phototherapy lamp from this link from (b)(6).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.Treat for skin disorders like psoriasis and eczema.Fda safety report id# (b)(4).

• Brand Name: UV PHOTOTHERAPY
• Type of Device: LIGHT, ULTRAVIOLET, DERMATOLOGICAL
• MDR Report Key: 11243791
• MDR Text Key: 229883645
• Report Number: MW5099072
• 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 Available for Evaluation?: Yes
• 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