BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 1231584 · Received November 13, 2008

    Report

    Report Number
    2135225-2008-00068
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    October 22, 2008
    Report Date
    November 12, 2008
    Manufacturer
    BIOFORM MEDICAL
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE POSSIBLE PULMONARY EMBOLISM WAS REPORTED BY BIOFORM MEDICAL FIELD CLINICAL SPECIALIST AND MEDICAL DIRECTOR CONSULTATION. NEITHER OF THESE PERSONNEL EVALUATED THIS PATIENT. THE INJECTION OF RADIESSE DERMAL FILLER INTO THE HANDS IS OFF-LABEL. NO DISCUSSION OF TREATMENT OF PULMONARY EMBOLISM WAS PROVIDED TO BFM. THE DEVICE HISTORY RECORDS FOR RADIESSE LOT 1010289 WERE REVIEWED, THIS LOT MET ALL TESTING SPECIFICATIONS.

    Description of Event or Problem · 1

    PATIENT WAS INJECTED WITH RADIESSE DERMAL FILLER IN ONE HAND. THE PHYSICIAN BELIEVED SHE SAW THE PRODUCT ENTER THE VEIN AND TRAVEL UP THE PATIENT'S ARM. LATER THAT NIGHT, THE PATIENT COUGHED UP BLOOD. THE PATIENT WAS NOT HOSPITALIZED. THE RADIESSE INJECTING PHYSICIAN REPORTED INTERMITTENT SWELLING AND INJECTED THE PATIENT WITH KENALOG TO TREAT THE SWELLING. THE PHYSICIAN HAS NOT CONFIRMED PULMONARY EMBOLISM TO BIOFORM MEDICAL INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH BIOFORM MEDICAL 1010289

    Patients

    Seq Age Sex Outcome Treatment
    1 Other