BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 1296989 · Received January 26, 2009

    Report

    Report Number
    2135225-2009-00004
    Event Type
    Injury
    Date Received
    January 26, 2009
    Date of Event
    December 29, 2008
    Report Date
    January 26, 2009
    Manufacturer
    BIOFORM MEDICAL, INC.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A FOLLOW-UP WITH THE PHYSICIAN, IT WAS REPORTED THE RESULTS OF BIOPSY WAS PSEUDOMONAS ANGINOSA, WHICH WAS TREATED WITH LEVAQUIN. THE PT'S INFECTION, SWELLING AND LUMP HAVE RESOLVED. THE DEVICE HISTORY RECORDS FOR RADIESSE LOT 1010942 WERE REVIEWED; THIS LOT MET ALL TESTING SPECIFICATIONS.

    Description of Event or Problem · 1

    PT WAS INJECTED WITH RADIESSE DERMAL FILLER IN THE MALAR AREA. ABOUT ONE WEEK POST INJECTION, THE PT DEVELOPED A LARGE, 3-CM LUMP ABOVE THE LEFT SIDE NASO LABIAL FOLD. THE PHYSICIAN INJECTED KENALOG, WHICH DID NOT HELP REDUCE THE LUMP. A BIOPSY OF THE LUMP WAS TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH BIOFORM MEDICAL, INC. 1010942

    Patients

    Seq Age Sex Outcome Treatment
    1 Other