BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIANCE, BIOFORM INJECTED INTO FACE

    MDR report key: 1335391 · Received February 23, 2009

    Report

    Report Number
    MW5010184
    Event Type
    Injury
    Date Received
    February 23, 2009
    Date of Event
    February 7, 2009
    Report Date
    February 21, 2009
    Manufacturer
    BIOFORM
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE USED RADIANCE SINCE 2007. WHILE IT IS PAINFUL AND THERE IS SOME BRUISING, IT DISAPPEARS WITHIN A FEW DAYS. HAD RADIANCE SHOTS IN FAINT SMILE LINE AND 2 LINES BY LOWER MOUTH. ON LEFT SIDE OF LOWER MOUTH DR SAID WOULD BE BRUISING. TURNED BLUE BLACK THAT AFTERNOON, THEN TURNED VERY BLACK WHERE HE HAD INJECTED AND STARTED TO ITCH BADLY. NEXT DAY RED APPEARED AROUND BLACK, SO 1/2 OF LOWER AREA UNDER MOUTH AFFECTED IN C SHAPE. ITCHING TURNED TO PAINFUL BURNING. LASTED 5 DAYS WITH BURNING. YELLOW CRACKED SCAB APPEARED. DR. SAW SAID THAT SHOT HAD BROUGHT OUT COLD SORES, BUT SCAB IN BLACKENED AREA. SCAB CAME OFF LEAVING SEVEN OVAL LUMPS THAT ARE VERY NOTICEABLE IN PINK PATCH WHERE BLACKENED SKIN WAS. I AM VERY UPSET SINCE I DO NOT KNOW IF OVAL CLUSTER OF LUMPS ARE PERMANENT OR NOT. DOSE OR AMOUNT: 1/2 SYRINGE; FREQUENCY: PROBABLY 2X A YEAR. DATES OF USE: 2007 - 2009. DIAGNOSIS OR REASON FOR USE: SMILE & MARIONETTE LINES ON FACE. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIANCE, BIOFORM INJECTED INTO FACE NONE LMH BIOFORM

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR