MAUDE Adverse Event Report: XUZHOU KERNEL MEDICAL INSTRUMENT EQUIPMENT CO LTD UV PHOTOTHERAPY; LIGHT, ULTRAVIOLET, DERMATOLIGICAL

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

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

Event Date 01/12/2021

Event Type  Injury  

Event Description

Burn my skin badly; i bought this months ago and have been trying it with my psoriasis hoping it would be amazing, however it was not.It irritated my skin when using it and left the skin feeling more of a burn than before.It is dangerous that this lamp burns people like me.It is a rx medical device and should be removed from (b)(6).Here is the link of the lamp: (b)(6).Fda safety report id# (b)(4).

• Brand Name: UV PHOTOTHERAPY
• Type of Device: LIGHT, ULTRAVIOLET, DERMATOLIGICAL
• Manufacturer (Section D): XUZHOU KERNEL MEDICAL INSTRUMENT EQUIPMENT CO LTD
• MDR Report Key: 11236356
• MDR Text Key: 229151950
• Report Number: MW5099018
• Device Sequence Number: 1
• Product Code: FTC
• 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: 01/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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): Life Threatening; Other; Required Intervention; Disability