MAUDE Adverse Event Report: ANGEL KISS CARE CO., LTD. ANGEL & KISS UV PHOTOTHERAPY LAMP; LIGHT, ULTRAVIOLET, DERMATOLOGICAL

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

Patient Problems Erythema (1840); Burn, Thermal (2530)

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 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.Psoriasis lamp.Fda safety report id # (b)(4).

• Brand Name: ANGEL & KISS UV PHOTOTHERAPY LAMP
• Type of Device: LIGHT, ULTRAVIOLET, DERMATOLOGICAL
• Manufacturer (Section D): ANGEL KISS CARE CO., LTD. ; #912, 913 gangseo hanhwa bizmetro 1st building; 551-17, yangcheon-ro gangseo-gu ; seoul teugbyeolsi 07532 ; KN 07532
• MDR Report Key: 11260937
• MDR Text Key: 230091145
• Report Number: MW5099113
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: 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; Disability