BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANGEL & KISS UV PHOTOTHERAPY LAMP

    MDR report key: 11285442 · Received February 4, 2021

    Report

    Report Number
    MW5099237
    Event Type
    Death
    Date Received
    February 4, 2021
    Date of Event
    January 14, 2021
    Report Date
    February 2, 2021
    Manufacturer
    ANGEL & KISS, LLC
    Product Code
    FTC
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178693 ANGEL & KISS UV PHOTOTHERAPY LAMP LIGHT, ULTRAVIOLET, DERMATOLOGICAL FTC ANGEL & KISS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| L| O| R| S