BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UV PHOTOTHERAPY

    MDR report key: 15893488 · Received November 30, 2022

    Report

    Report Number
    MW5113541
    Event Type
    Injury
    Date Received
    November 30, 2022
    Date of Event
    April 20, 2022
    Report Date
    November 28, 2022
    Manufacturer
    XUZHOU KERNEL MEDICAL INSTRUMENT EQUIPMENT CO.
    Product Code
    FTC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I BOUGHT A UV PHOTOTHERAPY LAMP FROM AMAZON A FEW MONTHS AGO. THE ITEM LINK IS WWW. AMAZON. COM/DP/B09LSC6WKY. MY SKIN WAS BURNED AND GOT WORSE AFTER APPLYING THIS. TRIED AGAIN YESTERDAY TO SEE IF MAYBE IT WAS JUST A FLUKE, BURNED EVEN WORSE AND IRRITATED THE SKIN MORE THAN IT ALREADY WAS. MY DERMATOLOGIST SAYS FDA RESTRICTS THIS PSORIASIS LAMP TO SELL WITHOUT THE ORDER OF A PHYSICIAN. ITS PACKAGE ALSO PROVES THIS. ITS 510K NUMBER IS K132643 WHICH CLEARLY SHOWS THAT THIS IS A PRESCRIPTION (RX) MEDICAL DEVICE. WHY FDA ALLOWS THIS RX PRODUCT SOLD ON AMAZON? I THINK FDA MUST REQUIRE TO REMOVE THIS ITEM. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348862 UV PHOTOTHERAPY LIGHT, ULTRAVIOLET, DERMATOLOGICAL FTC XUZHOU KERNEL MEDICAL INSTRUMENT EQUIPMENT CO. KN-4003BL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other