BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIANCE FN

    MDR report key: 479892 · Received August 19, 2003

    Report

    Report Number
    2135225-2003-00003
    Event Type
    Other
    Date Received
    August 19, 2003
    Date of Event
    July 24, 2003
    Report Date
    August 19, 2003
    Manufacturer
    BIOFORM, INC.
    Product Code
    LMH
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAD FACIAL TISSUE INJECTED WITH RADIANCE FN PRODUCT (OFF LABEL USE) ON TWO SEPARATE OCCASIONS. PT CONTACTED DOCTOR IN 2003 WITH AREAS OF SWELLING IN SITES WHERE INJECTIONS WERE MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIANCE FN INJECTABLE IMPLANT LMH BIOFORM, INC. 8027-3 C1102109

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other