BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFECTIO PLUS

    MDR report key: 21891753 · Received April 23, 2025

    Report

    Report Number
    MW5169449
    Event Type
    Injury
    Date Received
    April 23, 2025
    Date of Event
    February 12, 2025
    Report Date
    April 18, 2025
    Manufacturer
    OMM IMPORTS, INC. D/B/A ZERO GRAVITY
    Product Code
    OHS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    TISSUE DAMAGE: I BEGAN USING THE ZERO GRAVITY SKIN PERFECTIO PLUS DEVICE AS DIRECTED, FOLLOWING THE INSTRUCTIONS PROVIDED. APPROXIMATELY 30 DAYS AFTER STARTING USE, I DEVELOPED BROWN SPOTS AROUND MY MOUTH AND UNDER MY EYES. I IMMEDIATELY DISCONTINUED USE OF THE DEVICE AND REPORTED THE ISSUE TO THE SPA COSMETICS (B)(6) WHERE I PURCHASED IT. THE SPA WAS UNABLE TO ASSIST ME, SO I CONTACTED THE MANUFACTURER DIRECTLY. HOWEVER, THEY ONLY REFERRED ME TO THE PRODUCT'S EFFICACY RESULTS AND STATED THAT THESE WERE NOT RECOGNIZED SIDE EFFECTS AND THEY COULD NOT HELP ME. DO NOT USE DRUGS OR DRINK ALCOHOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628027 PERFECTIO PLUS LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION OHS OMM IMPORTS, INC. D/B/A ZERO GRAVITY PERFECTIO900

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Other ONCE-DAILY WOMEN'S SUPPLEMENT.