BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UV PHOTOTHERAPY LAMP

    MDR report key: 11285597 · Received February 4, 2021

    Report

    Report Number
    MW5099243
    Event Type
    Injury
    Date Received
    February 4, 2021
    Date of Event
    January 24, 2021
    Report Date
    February 3, 2021
    Manufacturer
    ANGEL KISS LLC.
    Product Code
    FTC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MY SKIN INFLAMED AND BURNED; I ORDERED A UV LAMP FROM (B)(6) I DON'T THINK THIS IS MEANT FOR DRY SKIN THAT IS AS SEVERE AS ECZEMA. IT WAS A VERY BAD BREAK OUT OF EXTREMELY SENSITIVE, CRACKED, AREAS WHERE SKIN HAD RIPPED FROM THE INTENSE DRYNESS AND LOCATION BEING ON THE INSIDE OF MY ELBOW WHERE MY SKIN IS PRONE TO EXTRA STRESS, AND BEGAN AS A 2 INCH DIAMETER PATCH. AFTER THIS PRODUCT, IT BECAME INFLAMED AND BURNED WHEN APPLIED. THE PATCH IS NOW SPREAD TO 4 INCHES AND DOWN TO ANOTHER PART OF MY ARM. I DON'T THINK THIS PRODUCT SHOULD BE USED FOR ANY TYPE OF ECZEMA RELATED SKIN ISSUE. FDA RESTRICTS THIS LAMP TO SELL WITHOUT THE ORDER OF A PHYSICIAN. ITS 510K NUMBER IS K132643 WHICH CLEARLY SHOWS THAT THIS IS A PRESCRIPTION (RX) MEDICAL DEVICE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178702 UV PHOTOTHERAPY LAMP LIGHT, ULTRAVIOLET, DERMATOLOGICAL FTC ANGEL KISS LLC. KN4003BL

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Life Threatening| O| R| S