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

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

Patient Problem Burn, Thermal (2530)

Event Date 01/14/2021

Event Type  Injury  

Event Description

Burned people skin; i am a dermatologist and received a patient suffering from psoriasis.He was burned heavily by a product from (b)(6) and had to go to hospital for recovery.I have checked that the product is a psoriasis lamp which will cause severe burning to people if they do not use this lamp under the direction of a licensed physician.That is a prescription (rx) medical device and should not be available online without prescription.I am showing you the link of this device on (b)(6).Fda should require (b)(6) to remove this device from its website to avoid more burning and hurt from psoriasis patient.Fda safety report id# (b)(4).

• Brand Name: UV PHOTOTHERAPY LAMP
• Type of Device: LIGHT, ULTRAVIOLET, DERMATOLOGICAL
• Manufacturer (Section D): ANGEL KISS LLC
• MDR Report Key: 11272503
• MDR Text Key: 230472316
• Report Number: MW5099163
• Device Sequence Number: 1
• Product Code: FTC
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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): Hospitalization; Life Threatening; Other