BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UV PHOTOTHERAPY

    MDR report key: 11229228 · Received January 25, 2021

    Report

    Report Number
    MW5099002
    Event Type
    Injury
    Date Received
    January 25, 2021
    Date of Event
    January 19, 2021
    Report Date
    January 21, 2021
    Manufacturer
    UNK
    Product Code
    FTC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I BOUGHT A UV PHOTOTHERAPY LAMP FROM (B)(6) A FEW DAYS AGO. THE ITEM LINK IS (B)(6). MY SKIN BURNED AND GOT WORSE AFTER APPLYING THIS. TRIED AGAIN THE NEXT DAY 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 (B)(6)? I THINK FDA MUST REQUIRE (B)(6) TO REMOVE THIS ITEM. FDA SAFETY REPORT ID # (B)(4). .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124300 UV PHOTOTHERAPY LIGHT, ULTRAVIOLET, DERMATOLOGICAL FTC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R| S