BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOBELLE

    MDR report key: 19415015 · Received May 28, 2024

    Report

    Report Number
    MW5155451
    Event Type
    Malfunction
    Date Received
    May 28, 2024
    Date of Event
    February 3, 2024
    Report Date
    May 24, 2024
    Manufacturer
    GCS CO.,LTD
    Product Code
    MOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WENT TO A COSMETICS CENTER (B)(6) TO DO BOTOX FILLER. UPON COMPLETION AND AFTER I PAID, I DID NOTICE THAT FILLERS HAVE EXPIRED 3-4 MONTHS PRIOR TO BEING DISTRIBUTED INTO MY FACE. I TRIED TO GET MY MONEY BACK BUT NO SUCCESS. THEN I WENT ON YOUR SITE TO RESEARCH ABOUT THE FILLER AND I SEE THAT THEY ARE NOT FDA APPROVED "INOBELLE", A KOREAN PRODUCT. FORTUNATELY I DO NOT SEE ANY SIDE EFFECT AS OF FEBRUARY BUT NO IMPROVEMENT EITHER. I AM JUST SHORT OF MY (B)(6). NAME OF THE COMPANY THAT MAKES (OR COMPOUNDS) THE PRODUCT: GLOBAL COMPANY FOR SKIN SCIENCE. REFERENCE REPORT: MW5155450.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1258507 INOBELLE ACID, HYALURONIC, INTRAARTICULAR MOZ GCS CO.,LTD IS21001

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female