BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 1893928 · Received November 2, 2010

    Report

    Report Number
    2135225-2010-00080
    Event Type
    Other
    Date Received
    November 2, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 11, 2010
    Manufacturer
    BIOFORM MEDICAL, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP PT NOTES INDICATES THAT THE REACTION HAS BEEN RESOLVED; THE CONDITION OF THE AFFECTED AREA HAS IMPROVED. ADDITIONALLY, THE PT WAS GIVEN A SAMPLE OF MINERAL MAKE-UP FOR COSMETIC PURPOSES. THE DEVICE HISTORY RECORDS FOR RADIESSE LOT 1015739 WERE REVIEWED; ALL REQUIRED TESTING SPECIFICATIONS HAD BEEN MET PRIOR TO RELEASE, AND THERE WERE NO ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    THE PHYSICIAN INJECTED A PT WITH RADIESSE DERMAL FILLER IN THE NL FOLDS ON (B)(6) 2010. TWO DAYS POST INJECTION, THE PT REPORTED PAIN IN THE NOSTRILS AND SWELLING ON THE LEFT SIDE, ALONG WITH RED/PURPLE COLORING AND WHITISH STREAKS. THE PT WAS SEEN BY THE INJECTING PHYSICIAN ON (B)(6) 2010 AND WAS PRESCRIBED PREDNISONE, CIPRO, AND DIFLUCAN. THE PHYSICIAN ALSO RECOMMENDED AQUAPHOR, WARM COMPRESSES AND VINEGAR SOAKS FOR THE PT. THE PHYSICIAN DIAGNOSED THE PT AS HAVING A ALLERGIC VASCULITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH BIOFORM MEDICAL, INC. 1015739

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention