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 01/19/2021

Event Type  Injury  

Event Description

I bought a uv phototherapy lamp from (b)(6) a few days ago.The item link is (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.My dermatologist says fda restricts this psoriasis lamp to sell without the order of a physician.Its package also proves this.Its 510k number is k132643 which clearly shows that this is a prescription (rx) medical device.Why fda allows this rx product sold on (b)(6)? i think fda must require (b)(6) to remove this item.Fda safety report id # (b)(4).

• Brand Name: UV PHOTOTHERAPY
• Type of Device: LIGHT, ULTRAVIOLET, DERMATOLOGICAL
• MDR Report Key: 11229228
• MDR Text Key: 229120278
• Report Number: MW5099002
• Device Sequence Number: 1
• Product Code: FTC
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/21/2021

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: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability