BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE

    MDR report key: 545407 · Received May 24, 2004

    Report

    Report Number
    MW1032648
    Event Type
    Other
    Date Received
    May 24, 2004
    Date of Event
    October 23, 2003
    Report Date
    May 24, 2004
    Manufacturer
    *
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RESTYLANE WAS INJECTED ABOVE CHIN AREA -BELOW LIPS ON THE RIGHT AN LEFT SIDES-. IT WAS NOT FDA APPROVED AT THAT DATE. THE PAIN OF THE INJECTIONS WAS EXTREME AND THE RESULTS WERE UNSATISFACTORY DUE TO THE LACK OF SPECIFIC PROFESSIONAL TRAINING AND EDUCATION ON THE CORRECT USE OF THE DEVICE, WHICH WOULD HAVE BEEN AVAILABLE ONCE FDA APPROVED. IN ADDITION, ONCE IT GAINED FDA APPROVAL ON DECEMBER 12, 2003, THE FDA ADVISORY PANEL NOTED THAT THERE WAS LIMITED DATA IN THE STUDY ON THE SAFETY OF RESTYLANE IN NON-CAUCASIANS. PT WAS NOT MADE AWARE OF ANY OF THE ABOVE ISSUES BEFORE OR DURING THE TIME OF THE INJECTIONS. THIS DECEPTIVE ACT IS, IN PT'S OPINION, DECLARED UNLAWFUL BY THE FDA AND THE MEDICAL BOARD. USE OF NON-FDA-APPROVED DRUGS AND DEVICES IS UNETHICAL AND ILLEGAL. AS A RESULT OF THIS DECEPTIVE ACT, PT SUFFERED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTYLANE * LMH * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other