BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 1444621 · Received August 17, 2009

    Report

    Report Number
    2135225-2009-00038
    Event Type
    Injury
    Date Received
    August 17, 2009
    Date of Event
    August 4, 2009
    Report Date
    August 6, 2009
    Manufacturer
    BIOFORM MEDICAL, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT# 1013196. PHYSICIAN PRESCRIBED ANTIBIOTIC CLINDAMYCIN AND MASSAGED AFFECTED AREA TO RELEASE PRESSURE ON A VEIN. HE STATED HER SYMPTOMS WERE COMBINATION OF PRESSURE ON A VEIN AND AN INFECTION DUE TO THE PRESENCE OF PUSTULES, AND PRONOUNCED ERYTHEMA. F/U WITH PHYSICIAN REPORTED THE CONTINUATION OF CLINDAMYCIN, TREATING THE AREA TOPICALLY WITH ANTIBIOTIC BACTROBAN AND ALSO PRESCRIBING 2-3 DAYS OF ORAL STEROIDS FOR THE PT. THE PT RETURNED THE FOLLOWING DAY SHOWING MUCH IMPROVEMENT TO THE AREA WITH BOTH PUSTULES AND REDNESS BEGINNING TO RESOLVE. THE DEVICE HISTORY RECORDS FOR RADIESSE DERMAL FILLER LOTS 1012825 AND 1013196 WERE REVIEWED; ALL REQUIRED TESTING MET SPECS AND THERE WERE NO ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    A PT WAS INJECTED IN THE NASO LABIAL FOLDS, MARIONETTE LINES, AND UPPER CHEEKS WITH RADIESSE DERMAL FILLER. TWO DAYS LATER, THE PT DEVELOPED SWELLING AND REDNESS FROM THE NASAL TIP TO THE SIDE OF NOSE, AND UP TO THE GLABELLA REGION. PUSTULES APPEARED THREE DAYS POST-INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH BIOFORM MEDICAL, INC. 1012825

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention