BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 3671942 · Received February 27, 2014

    Report

    Report Number
    2135225-2014-00006
    Event Type
    Other
    Date Received
    February 27, 2014
    Date of Event
    December 19, 2013
    Report Date
    February 10, 2014
    Manufacturer
    MERZ NORTH AMERICA, INC
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR RADIESSE LOT 1033352 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

    REPORT WAS RECEIVED FROM A (B)(6) PHYSICIAN WHO INJECTED A PT WITH 1.5 ML OF RADIESSE INTO CHEEKBONES, CHEEKS, AND MARIONETTE LINES. TWO HOURS AFTER TREATMENT WITH RADIESSE, THE PT PRESENTED SEVERE SWELLING OF THE FACE. THE EVENT WAS FURTHER DESCRIBED AS SPREADING, AT FIRST PERIORALLY AND THEN OVER THE WHOLE FACE AND INTRAORALLY. CORRECTIVE TREATMENT COMPRISED OF INTRAVENOUS SOLU-DECORTIN H 50 MG (PREDNISOLONE SODIUM SUCCINATE), AERIUS (DESLORATADINE) AND DEXAPOS (CARMELLOSE, DEXAMETHASONE SODIUM METASULFOBENZOATE) EYE DROPS. THE EVENT RESOLVED SIX WEEKS AFTER ONSET. IN THE OPINION OF THE REPORTING PHYSICIAN, THE EVENT WAS OF SEVERE INTENSITY, AND PRESENTED A SERIOUS DETERIORATION IN THE PT'S STATE OF HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121113 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ NORTH AMERICA, INC 1033352

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention 0.25 ML XYLONEST (PRILOCAIN) INJECTION| BLOPRESS