BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 1165053 · Received September 16, 2008

    Report

    Report Number
    2135225-2008-00054
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    July 19, 2008
    Report Date
    September 15, 2008
    Manufacturer
    BIOFORM MEDICAL, INC.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BIOFORM MEDICAL INC. RECEIVED AN INITIAL REPORT IN 2008; PT WAS INJECTED WITH RADIESSE DERMAL FILLER IN THE NASOLABIAL FOLDS AND DEVELOPED REDNESS, SWELLING WITH RED STREAKS ON HER CHEEKS. SHE WAS TREATED WITH BACTROBAN TOPICAL OINTMENT. ON 09/09/2008 BIOFORM MEDICAL RECEIVED ADDITIONAL INFO. THE PT HAD A SEVERE INFECTION; SHE WAS INJECTED IN THE NASOLABIAL FOLDS AND SHE DEVELOPED A BLACK AREA NEAR THE NOSTRIL. SHE WAS TREATED WITH ORAL LEVAQUIN. THE INFECTION HAS RESOLVED, BUT SHE STILL HAS SOME DISCOLORATION WHERE THE INFECTION HAD OCCURRED.

    Description of Event or Problem · 1

    PT WAS INJECTED IN THE NASOLABIAL FOLDS WITH RADIESSE DERMAL FILLER; THE FOLLOWING DAY, SHE DEVELOPED AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH BIOFORM MEDICAL, INC. 8046M0K1 1009981

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention