BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 3488884 · Received November 1, 2013

    Report

    Report Number
    2135225-2013-00102
    Event Type
    Other
    Date Received
    November 1, 2013
    Date of Event
    September 27, 2013
    Report Date
    September 30, 2013
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FOLLOW-UP DR (B)(6) REPORTED THE PT IS DOING MUCH BETTER AND ALL OF THE SCABS HAVE COME OFF REVEALING NEW SLIGHTLY ERYTHEMATOUS SKIN. DR (B)(6) WILL CONTINUE TO MONITOR THE PT AND SHE IS DUE TO RETURN IN ONE MONTH. THE DEVICE HISTORY RECORD FOR RADIESSE LOT # 100065508 WAS REVIEWED. ALL REQUIRED INCOMING, IN PROCESS, AND FINAL RELEASE TESTING SPECIFICATIONS FOR THIS LOT WERE MET PRIOR TO RELEASE. NO NON-CONFORMANCES WERE DISCOVERED THAT WOULD HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    DR (B)(6) INJECTED A (B)(6) FEMALE PT WITH 0.8 CC OF RADIESSE IN THE LEFT CHEEK ON (B)(6) 2013. ON (B)(6) 2013 THE PT REPORTED PUFFINESS AND A HOT RED PATCH WITH A STINGING FEELING AS THOUGH SHE HAD BEEN BURNED. DR (B)(6) PRESCRIBED KEFLEX AND ACYCLOVIR FOR TREATMENT. A CONSULT FOR DR (B)(6) WAS PROVIDED BY (B)(4) MEDICAL (B)(4), DR (B)(6) ON (B)(6) 2013. DR (B)(6) DISCUSSED APPROPRIATE WOUND CARE WITH DR (B)(6) INCLUDING THE USE OF WARM COMPRESSES AND NITROPASTE. DR (B)(6) SENT DR (B)(6) HER WOUND CARE PROTOCOL AND TWO ARTICLES ON THE SUBJECT OF NECROSIS AFTER FILLERS. ALSO DISCUSSED WAS THE USE OF ANTIBIOTICS AND ANTIVIRAL IN THIS CASE AND DR (B)(6) IS AWARE THE ETIOLOGY OF THE SKIN BREAKDOWN IS NOT INFECTIOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563966 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ NORTH AMERICA, INC. 100065508

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention RADIESSE MIXED WITH 0.15 CC OF 2% LIDOCAINE