MAUDE Adverse Event Report: ANGEL KISS LLC. PSORIASIS UV PHOTOTHERAPY LAMP; LIGHT, ULTRAVIOLET, DERMATOLOGICAL

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Skin Burning Sensation (4540)

Event Date 01/18/2021

Event Type  Injury  

Event Description

I am a physician and got a psoriasis patient recently.He used a lamp from (b)(6) but got burned deadly.The lamp causes increased burning and redness to his elbow psoriasis.He had to stop using after 2 days and thoroughly wash skin to alleviate intense burning.The lamp is a is a prescription (rx) medical device which clearly shows in its package and manual.I think (b)(6) is forbidden to sell this online without prescription.The link of the lamp is (b)(6).(b)(6) should remove this.Fda safety report id# (b)(4).

• Brand Name: PSORIASIS UV PHOTOTHERAPY LAMP
• Type of Device: LIGHT, ULTRAVIOLET, DERMATOLOGICAL
• Manufacturer (Section D): ANGEL KISS LLC.
• MDR Report Key: 11278741
• MDR Text Key: 230479518
• Report Number: MW5099212
• Device Sequence Number: 1
• Product Code: FTC
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/02/2021

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?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Disability