BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNILUX MASK

    MDR report key: 13417947 · Received January 31, 2022

    Report

    Report Number
    MW5107110
    Event Type
    Injury
    Date Received
    January 31, 2022
    Date of Event
    October 28, 2021
    Report Date
    January 31, 2022
    Manufacturer
    GLOBALMED TECHNOLOGIES CO.
    Product Code
    OLP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    REPORTER USED OMNILUX MASK AND HER FACE WAS LEFT DRY, IRRITATED SKIN WITH DARK PIGMENTATION. REPORTER COMPLAINS THAT SHE SUFFERS WITH BLURRY VISION FROM THE LIGHT THERAPY. "WHILE USING THE MASK IT BECOMES WARM TO TOUCH AND IT SHOULDN'T." SHE HAS USED LIGHT THERAPY IN THE PAST AND NOTICED THE LIGHT BULBS ARE DIFFERENT FROM THE LAST DEVICE. WHILE ON A SOCIAL MEDIA FORUMS ALL OF THE PEOPLE WHO USED THIS DEVICE HAD THE SAME COMPLAINTS OF SKIN INFLAMMATION. REPORTER STATES THAT SHE'S TRIED TO CONTACT THE MANUFACTURER AND RECEIVED A "CANNED RESPONSE" EMAIL. "THIS SEEMS TO BE A SUPPLY CHAIN PROBLEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1386346 OMNILUX MASK OVER-THE-COUNTER POWERED LIGHT BASED LASER FOR ACNE OLP GLOBALMED TECHNOLOGIES CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention| O