BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UV PHOTOTHERAPY

    MDR report key: 11272394 · Received February 2, 2021

    Report

    Report Number
    MW5099156
    Event Type
    Injury
    Date Received
    February 2, 2021
    Date of Event
    January 22, 2021
    Report Date
    February 4, 2021
    Manufacturer
    ANGEL KISS LLC
    Product Code
    FTC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BURNED MY SKIN; MY HUSBAND BOUGHT ME THIS LAMP BECAUSE I HAD ECZEMA DYSHIDROTIC ON MY PALM AND AROUND MY FINGERS. THIS LAMP DIDN'T HELP AT ALL. I WAS STILL ITCHING, BURNING AND SKIN WAS BREAKING OUT NONSTOP. I ONLY USED IT FOR 3 DAYS AND GAVE UP BECAUSE I FELT LIKE IT WASN'T SPEEDING UP THE PROCESS OR HELPING ME HEAL. THE LINK IS HERE (B)(6). ITS 510K NUMBER IS K132643 WHICH CLEARLY SHOWS THAT THIS IS A PRESCRIPTION (RX) MEDICAL DEVICE. (B)(6) WILL BE PUNISHED IF (B)(6) DON'T TAKE THIS CASE SERIOUS TO REMOVE IT. FDA SAFETY REPORT ID# (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFO RECEIVED ON 02/04/2021 FROM REPORTER FOR MW5099156. THE REPORTER HAS ADDED PATIENT INFORMATION, REPORTER ADDRESS, AND THE OPERATOR OF THE DEVICE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161038 UV PHOTOTHERAPY LIGHT, ULTRAVIOLET, DERMATOLOGICAL FTC ANGEL KISS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization| L| O| R| S