BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNILUX CONTOUR

    MDR report key: 19659287 · Received July 1, 2024

    Report

    Report Number
    MW5156924
    Event Type
    Injury
    Date Received
    July 1, 2024
    Date of Event
    June 10, 2024
    Report Date
    June 27, 2024
    Manufacturer
    GLOBALMED TECHNOLOGIES CO.
    Product Code
    OHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    HAIR GROWTH ON FACE. I PURCHASED FDA APPROVED OMNILUX CONTOUR FACE MASK. I HAVE USED IT FOR SEVERAL MONTHS AND HAVE REALIZED THAT I HAVE NOTICEABLE HAIR GROWTH ALLOVER MY FACE. NATURALLY, I HAD A SOME PEACH FUZZ ON MY SKIN BUT NOW THE DARK HAIR AND SOME COARSE ONE AS WELL. THERE SEEMS TO BE OTHER PEOPLE HAVING THIS ISSUE. CONTACTED OMNILUX AND THEY CONFIRMED THAT SOME HAVE NOTICED HAIR GROWTH BUT THIS INFORMATION IS NOT DISCLOSED ON THEIR WEBSITE. I CANNOT RETURN THE PRODUCT BECAUSE IT IS PAST RETURN DATE AND NOW I HAVE TO PAY FOR HAIR LASER REMOVAL. USING PRODUCT FOR: ANTI-AGING. DATES OF USE: (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551154 OMNILUX CONTOUR LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION OHS GLOBALMED TECHNOLOGIES CO. 5223TN

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Other AMBIEN| B-COMPLEX| ETODOLAC| METOPROLOL | REMICADE INFUSION | TYLENOL | VIT D3| ZINC | ZOLOFT