BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIANCE FN

    MDR report key: 481550 · Received August 26, 2003

    Report

    Report Number
    2135225-2003-00004
    Event Type
    Other
    Date Received
    August 26, 2003
    Manufacturer
    BIOFORM, INC.
    Product Code
    GDW
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DOCTOR INADVERTANTLY INJECTED A PATIENT WITH A SAMPLE OF RADIANCE FN MEDIA LABELED NOT INTENDED FOR CLINICAL USE. THERE HAS BEEN NO REPORTED PATIENT REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIANCE FN INJECTABLE IMPLANT GDW BIOFORM, INC. 5001 M02232

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other