BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILLUMASK

    MDR report key: 3866730 · Received June 4, 2014

    Report

    Report Number
    MW5036508
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    LA LUMIERE, LLC
    Product Code
    OLP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER USING THE DEVICE I NOTICED MY VISION WAS BLURRED AND I EXPERIENCED DISTORTED COLORS IN MY VISION TEMPORARILY. DATES OF USE: (B)(6) 2014. REASON FOR USE: ANTI-AGING - REDUCE FINE LINES AND WRINKLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327261 ILLUMASK ACNE LIGHT OLP LA LUMIERE, LLC NP4048014017C1

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR