BEUDAMED
    FDA Adverse Event Summary report: N

    RADIESSE

    MDR report key: 570524 · Received February 2, 2005

    Report

    Report Number
    MW4003865
    Date Received
    February 2, 2005
    Date of Event
    May 1, 2004
    Report Date
    December 7, 2004
    Manufacturer
    *
    Product Code
    LMH
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAS HAD PERMANENT LIP DISFIGUREMENT AS A RESULT OF FOUR RADIESSE (FORMERLY CALLED RADIANCE) INJECTIONS IN 2004. REPORTER STATED THAT THIS PRODUCT IS NOT APPROVED FOR LIP AUGMENTATION. THIS PRODUCT IS REGULATED AS A DEVICE PER 21 CFR 874.3620. REPORTER STATED THAT DR IS PROMOTING THIS PRODUCT AS APPROVED BY FDA FOR LIP AUGMENTATION (OFF-LABEL USE) VIA A BROCHURE WHICH IS HAND DELIVERED TO BEAUTY PARLORS IN AREAS SINCE DR HAS OFFICES IN ALL THREE LOCATIONS. REPORTER CONTACTED THE DEPT. OF HEALTH BOARD OF MEDICINE ABOUT DR'S ACTIVITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE EAR, NOSE, AND THROAT SYNTHETIC POLYMER MATERIAL LMH * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR