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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Burn(s) (1757); Death (1802)

Event Date 01/14/2021

Event Type  Death  

Event Description

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), (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: ANGEL & KISS UV PHOTOTHERAPY LAMP
• Type of Device: LIGHT, ULTRAVIOLET, DERMATOLOGICAL
• Manufacturer (Section D): ANGEL & KISS, LLC
• MDR Report Key: 11285442
• MDR Text Key: 230730032
• Report Number: MW5099237
• 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

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• 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): Death; Hospitalization; Life Threatening; Other; Required Intervention; Disability