BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 3190133 · Received June 17, 2013

    Report

    Report Number
    2135225-2013-00075
    Event Type
    Other
    Date Received
    June 17, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 20, 2013
    Manufacturer
    MERZ AESTHETICS INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS FOR RADIESSE LOT WERE REVIEWED. ALL REQUIRED TESTING SPECIFICATIONS FOR THE LOT WERE MET PRIOR TO RELEASE. NO NON-CONFORMANCES WERE DISCOVERED THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    DR (B)(6) INJECTED A FEMALE PATIENT WITH 1.5 CC RADIESSE INTO NASOLABIAL FOLDS AND MARIONETTE LINES. THE PATIENT PRESENTED WITH PAINFUL BLISTERS INSIDE THE MOUTH. BLISTERS WERE CULTURED AND CAME BACK NEGATIVE. BLISTERS WERE ALSO FIRM TO THE TOUCH, NOT WARM, VERY PAINFUL, AND THERE WERE NO ABSCESSES. DR (B)(6) TREATED THE PATIENT WITH PREDNISONE, KEFLEX, AND VALTREX, DOSE, FREQUENCY AND DURATION WERE NOT PROVIDED; AND THE BLISTERS RESOLVED WITHIN A FEW DAYS. THE PATIENT WAS TREATED A TOPICAL BLT TOPICAL ANESTHETIC PRIOR TO TREATMENT WHICH HAS SINCE BEEN THROWN OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273964 RADIESSE DERMAL FILLER RADIESSE INJECTABLE IMPLANT LMH MERZ AESTHETICS INC. 100063704

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention BLT TOPICAL ANESTHETIC