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

Device Problem Product Quality Problem (1506)

Patient Problems Itching Sensation (1943); Burn, Thermal (2530)

Event Date 01/16/2021

Event Type  Injury  

Event Description

I bought a lamp from (b)(6).I used it for a few days and found it to be overly drying and made me incredibly itchy, and it also burned my skin badly and have to go to hospital.It says that this is a prescription (rx) medical device in its package and manual.Why it is available on (b)(6) for sale to individual like me without prescription.It should be restricted on (b)(6).Fda safety report id # (b)(4).

• Brand Name: UV PHOTOTHERAPY
• Type of Device: LIGHT, ULTRAVIOLET, DERMATOLOGICAL
• MDR Report Key: 11229246
• MDR Text Key: 229103908
• Report Number: MW5099003
• 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: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• 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; Other; Required Intervention