BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 1056177 · Received March 28, 2008

    Report

    Report Number
    2135225-2008-00021
    Event Type
    Other
    Date Received
    March 28, 2008
    Report Date
    March 28, 2008
    Manufacturer
    BIOFORM MEDICAL, INC.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS RECEIVED THROUGH A MEDWATCH REPORT, FILED WITH THE FDA. A REVIEW OF THE REPORTED ADVERSE EVENTS AT BIOFORM MEDICAL, INC. INDICATES THAT THIS EVENT HAD NOT BEEN SUBMITTED TO BFM PREVIOUSLY. THIS EVENT REPORT IS BEING FILED DUE TO THE ALLEGED SERIOUSNESS OF THE COMPLAINT, SUCH THAT THE NODULES REQUIRED SURGICAL INTERVENTION AND RECONSTRUCTION. THE PHYSICIAN WAS CONTACTED FOR ADDITIONAL INFO, BUT DID NOT RETURN ANY CALLS. RADIESSE IS NOT APPROVED FOR USE IN THE LIPS IN THE UNITED STATES. THE LOT NUMBERS FOR RADIESSE DERMAL FILLER WAS NOT PROVIDED; THEREFORE, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    THE FOLLOWING REPORT HAD BEEN SUBMITTED TO BIOFORM MEDICAL, INC. VIA FDA'S MEDWATCH PROGRAM. DR. REPORTED DISLIKE OF THE USE OF SCULPTRA, ARTEFILL AND RADIESSE, DUE TO A HIGH FREQUENCY OF AES AND FEELS THAT THE FDA SHOULD NOT HAVE ALLOWED APPROVALS FOR USE IN THE UNITED STATES. HE REPORTED THAT IN A PUBLISHED STUDY OF 90 RADIESSE PTS, 36% DEVELOPED NODULES. DR. INDICATED THAT HE HAD ONE PT WHO WAS SO DISTRAUGHT OVER NODULES DEVELOPED IN HER LIPS, THAT SHE REQUIRED SURGERY AND RECONSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH BIOFORM MEDICAL, INC. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention