BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 985555 · Received January 23, 2008

    Report

    Report Number
    2135225-2008-00005
    Event Type
    Injury
    Date Received
    January 23, 2008
    Date of Event
    May 1, 2007
    Report Date
    January 22, 2008
    Manufacturer
    BIOFORM MEDICAL
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DR. REQUESTED A CONSULT WITH ONE OF BIOFORM'S MEF'S, IT WAS THOUGHT TO BE A STAPH INFECTION AND THE INFECTION DID RESOLVE. INJECTING RADIESSE DERMAL FILLER INTO THE GLABELLA IS CONSIDERED AN OFF LABEL USE. THE LOT NUMBERS FOR RADIESSE DERMAL FILLER WAS NOT PROVIDED; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE MEDICAL DEVICE REPORT DECISION TREES WERE COMPLETED FOR FDA, WHEN THE COMPLAINT WAS FIRST RECEIVED; IT WAS NOT THOUGHT AT THE TIME THE INFECTION WAS SERIOUS ENOUGH TO FILE AN MDR. IN DOING A SECOND REVIEW OF THE COMPLAINT AND MDR DECISION TREES, AN MDR WILL BE FILED WITH THE FDA DUE TO THE SERIOUSNESS OF THE INFECTION (REQUIRED AN ORAL ANTIBIOTIC).

    Description of Event or Problem · 1

    PATIENT WAS INJECTED WITH RADIESSE DERMAL FILLER INTO THE NASOLABIAL FOLDS, GLABELLA AND MARIONETTE LINES. THE AREA AROUND THE GLABELLA BECAME RED AND SWOLLEN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention