BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 1001921 · Received February 21, 2008

    Report

    Report Number
    2135225-2008-00011
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    January 11, 2008
    Report Date
    February 20, 2008
    Manufacturer
    BIOFORM MEDICAL, INC.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT REPORTED THAT SHE WAS INJECTED IN THE GLABELLA WITH RADIESSE DERMAL FILLER, WHEN SHE WAS INJECTED IT WAS VERY PAINFUL. WHEN THE PT WAS AT HOME THE AREA HAD TURNED WHITE. FOUR DAYS LATER THE AREA BEGAN DRAINING. PT RETURNED TO THE INJECTING PHYSICIAN AND WAS DIAGNOSED WITH A CELLULITIS AND AN OCCLUDED VEIN. THE PT WAS PRESCRIBED AZROTHMYCIN PO, BID, NITRO-BID OINTMENT AND BACTROCIN TOPICAL OINTMENT. THE AREA IS HEALING WITH OUT PROBLEMS. INJECTION INTO THE GLABELLA IS AN OFF LABEL USE.

    Description of Event or Problem · 1

    PT WAS INJECTED WITH RADIESSE DERMAL FILLER IN THE GLABELLAR. WHEN BEING INJECTED IT WAS VERY PAINFUL IN ONE INJECTION SITE. WHEN THE PT WAS AT HOME SHE NOTICED THE AREA HAD TURNED WHITE, FOUR DAYS LATER THE AREA STARTED DRAINING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention