BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIANCE FN

    MDR report key: 536160 · Received July 22, 2004

    Report

    Report Number
    2135225-2004-00012
    Event Type
    Other
    Date Received
    July 22, 2004
    Date of Event
    July 6, 2004
    Report Date
    July 21, 2004
    Manufacturer
    BIOFORM MEDICAL INC.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    VIA-E-MAIL, THIS PT CLAIMS THAT THEY HAD THEIR LIPS INJECTED WITH RADIANCE TWO WEEKS PRIOR TO NOTIFYING BIOFORM MEDICAL INC. OF THIS EVENT. THEY DESCRIBE THEIR LIPS AS HAVING NODULES. THIS PT INDICATED THAT THE NODULES COULD NOT BE MASSAGED OUT. THEY ALSO SAID THAT THEIR DOCTOR COULD NOT EXCISE THEM IN HIS OFFICE AND THEY WILL HAVE THEM SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIANCE FN INJECTABLE IMPLANT LMH BIOFORM MEDICAL INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention