BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 1415248 · Received July 15, 2009

    Report

    Report Number
    2135225-2009-00034
    Event Type
    Other
    Date Received
    July 15, 2009
    Date of Event
    June 9, 2009
    Report Date
    June 30, 2009
    Manufacturer
    BIOFORM MEDICAL, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A FOLLOW-UP WITH THE CLINIC, IT WAS REPORTED THAT THE INFECTION HAS RESOLVED. THERE IS A SMALL AREA OF REDNESS STILL PRESENT. THE DEVICE HISTORY RECORDS FOR RADIESSE DERMAL FILLER LOT 1013549 WERE REVIEWED; ALL REQUIRED TESTING MET SPECIFICATIONS AND THERE WERE NO DEVIATIONS NOTED.

    Description of Event or Problem · 1

    A PT WAS INJECTED IN THE NASO LABIAL FOLDS WITH RADIESSE DERMAL FILLER; ONE DAY POST INJECTION, THE PT DEVELOPED AN INFECTION CLOSE TO THE LEFT NASAL ALAR. THE PT WAS TREATED WITH DICLOX (ANTIBIOTIC), BACTROBAN (TOPICAL ANTIBIOTIC OINTMENT) AND AUGMENTIN (ANTIBIOTIC).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH BIOFORM MEDICAL, INC. 1013549

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention