BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIANCE; BIOFORM CO

    MDR report key: 514451 · Received February 13, 2004

    Report

    Report Number
    MW1031357
    Event Type
    Malfunction
    Date Received
    February 13, 2004
    Report Date
    February 13, 2004
    Manufacturer
    BIOFORM INC.
    Product Code
    LMH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2003 PT WAS INJECTED AT EITHER SIDES OF THEIR MOUTH WITH 4 SYRINGES OF RADIANCE FN, MFG BY THE BIOFORM CO. IT HAS NEVER BEEN REPORTED TO MIGRATE. TWO MOS LATER PT HAD A FIFTH SYRINGE INJECTED. NEITHER OF THESE WERE NEAR THE FIRST MIGRATION SITE ON THEIR NECK UNDER THEIR CHIN IN THE CENTER UNDER THEIR JAW. NEAR THE END OF SEPT OF 2003 PT FELT A SHARP LUMP ON THEIR NECK ABOUT ONE INCH UNDER THE CENTER OF THEIR CHIN. PT COULD ALSO FEEL A LARGER AND SOFTER LUMP TO THE LEFT OF IT. THEIR DERMATOLOGIST SUGGESTED PT HAVE IT REMOVED AND BIOPSIED. IT WAS DESCRIBED AS RADIANCE BY BOTH PHYSICIANS AS THEY REMOVED AND EXAMINED THE TISSUES WITH IT INTERSPERSED. THEY SHOWED PT AS WELL. PT HAS A GOOD SIZED SCAR NOW AND ANOTHER LUMP HAS FORMED. THE CO CONTENDS THAT THERE WAS A CHANNEL MADE BY NEEDLE OR SOME THING THAT ALLOWED THE MIGRATION TO A DISTANT SPOT. PT FELT WHERE THE SYRINGE WENT IN AND THAT WAS NOT NEAR THE MIGRATION SITE. PT WAS WONDERING HOW MANY CASES WERE NOT REPORTED FOR WHATEVER REASON. PT FEELS IT IS THEIR DUTY TO SAVE OTHERS THIS PAIN AND UNK FURTURE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIANCE; BIOFORM CO * LMH BIOFORM INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other