BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOOST ADVANCED LED LIGHT THERAPY FACE MASK

    MDR report key: 9793147 · Received March 4, 2020

    Report

    Report Number
    MW5093530
    Event Type
    Injury
    Date Received
    March 4, 2020
    Date of Event
    January 8, 2020
    Report Date
    March 2, 2020
    Manufacturer
    THE LIGHT SALON BOOST LIMITED
    Product Code
    OHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON 5TH USE OF BOOST FACE MASK (MANUFACTURED BY THE LIGHT SALON) SUFFERED TRANSIENT VISION LOSS / BLURRED VISION OF 2 MINS IN DURATION WITH FLASH BURNS TO EYES. MASK DID NOT COME WITH EYE GOGGLES; I HAD PLACED A BLANKET OVER MY EYES (TO COVER THEM DURING MASK USE) FOR THE CYCLE. SUBSEQUENT F/U WITH OPHTHALMOLOGIST CONFIRMED FLASH BURNS TO EYES. PLACED ON ANTIBIOTICS. TO DATE, NO PERMANENT VISION LOSS APPEARS TO HAVE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253479 BOOST ADVANCED LED LIGHT THERAPY FACE MASK LIGHT BASED OVER THE COUNTER WRINKLE OHS THE LIGHT SALON BOOST LIMITED 10 1019KY

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR