BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 1258172 · Received December 3, 2008

    Report

    Report Number
    2135225-2008-00071
    Event Type
    Other
    Date Received
    December 3, 2008
    Date of Event
    November 6, 2008
    Report Date
    December 2, 2008
    Manufacturer
    BIOFORM MEDICAL
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE POSSIBLE NECROSIS, DUE TO INJECTION SITE BLANCHING WAS REPORTED TO BIOFORM MEDICAL. DURING A FOLLOW-UP WITH THE PHYSICIAN, IT WAS REPORTED THAT THE PT'S SYMPTOMS WERE RESOLVING. DIAGNOSIS OF NECROSIS WAS NOT CONFIRMED BY THE PHYSICIAN AND NO ADDITIONAL INFO WAS REPORTED. THE DEVICE HISTORY RECORDS FOR RADIESSE LOT 1011071 WERE REVIEWED; THIS LOT MET ALL TESTING SPECIFICATIONS.

    Description of Event or Problem · 1

    PT WAS INJECTED WITH RADIESSE DERMAL FILLER IN CHEEKS, NASOLABIAL FOLDS AND MARIONETTE LINES. THERE WAS NOTICEABLE BLANCHING ON ONE SIDE, AT THE TIME OF THE INJECTIONS. THE PT DEVELOPED SWELLING, PAIN AND CRUSTING ON ONE SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH BIOFORM MEDICAL 1011071

    Patients

    Seq Age Sex Outcome Treatment
    1 Other