BEUDAMED
    FDA Adverse Event Injury Summary report: N

    311NNM NARROWAND UV PHTOTHERAPY LIGHT LAMP

    MDR report key: 16043356 · Received December 22, 2022

    Report

    Report Number
    MW5113969
    Event Type
    Injury
    Date Received
    December 22, 2022
    Date of Event
    December 1, 2022
    Report Date
    December 6, 2022
    Manufacturer
    XUZHOU KERNEL MEDICAL INSTRUMENT EQUIPMENT CO LTD.
    Product Code
    FTC
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    BURN MY SKIN, IT IRRITATED MY SKIN WHEN USING IT AND LEFT THE SKIN FEELING MORE OF A BURN THAN BEFORE. IT IS DANGEROUS THAT THIS LAMP BURNS PEOPLE LIKE ME. ALTHOUGH IT HAS 510K, K181805, BUT IT IS A RX MEDICAL DEVICE AND SHOULD BE REMOVED FROM AMAZON. HERE IS THE LINK OF THE LAMP WWW.AMAZON.COM/DP/B08H1VRMCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2261459 311NNM NARROWAND UV PHTOTHERAPY LIGHT LAMP LIGHT, ULTRAVIOLET, DERMATOLOGICAL FTC XUZHOU KERNEL MEDICAL INSTRUMENT EQUIPMENT CO LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention