BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 3437455 · Received October 25, 2013

    Report

    Report Number
    2135225-2013-00109
    Event Type
    Other
    Date Received
    October 25, 2013
    Date of Event
    September 24, 2013
    Report Date
    September 25, 2013
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2013 DR (B)(6) WAS CONTACTED AND HE STATED THAT THE PT WAS DOING MUCH BETTER. THE DEVICE HISTORY RECORD FOR THE REPORTED RADIESSE LOT NUMBER WAS REVIEWED. ALL REQUIRED INCOMING, IN PROCESS, AND FINAL RELEASE TESTING SPECIFICATIONS FOR THIS LOT WERE MET PRIOR TO RELEASE. NO NON-CONFORMANCE WERE DISCOVERED THAT WOULD HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    A MERZ NORTH AMERICA, INC. TERRITORY MANAGER, (TM) WAS CALLED BY THE INJECTING PHYSICIAN, DR (B)(6) ON (B)(6) 2013. DR (B)(6) INJECTED A PT WITH RADIESSE. THE PT BEGAN TO SWELL AND DEVELOP HIVES. HE SENT THE PT TO THE EMERGENCY DEPARTMENT FOR BLOOD WORK AND EVALUATION. ON (B)(6) 2013 THE TM REPORTED THAT HE WAS INFORMED THAT THE PT WAS CHECKED INTO THE HOSPITAL. THERE IS A SYSTEMIC REACTION WITH HIVES, THERE WAS A CARDIAC EVENT. ON (B)(64 )2013 DR (B)(6) STATED THAT THIS IS A (B)(6) FEMALE PT, INITIALS (B)(6). ON (B)(6) 2013 SHE WAS INJECTED WITH TWO RADIESSE SYRINGES (BOTH LOT 100065428). THE TWO SYRINGES WERE INJECTED INTO BOTH CHEEKS, ML, NLF. THE PT DID VERY WELL AND THERE WAS NO REACTION. THE NEXT DAY SHE HAD FACIAL SWELLING. TO CLEAN THE AREA ALCOHOL AND HIBICLENS WAS USED. AT FIRST HE THOUGHT INFECTION. THEN THERE WAS A RASH AND SWELLING ON BOTH SIDES. THEN IT WENT DOWN HER LEGS. DR (B)(6) SENT THE PT TO THE ER. THE ER GAVE THE PT CORTISONE. THE HOSPITAL KEPT THE PT AS SHE WAS ALSO HAVING CHEST PAIN. A STRESS TEST IS BEING PERFORMED. DR (B)(6) EXPLAINED THAT THE PT WAS GIVEN STEROIDS, HAD A SYSTEMIC REACTION AND THE SWELLING IN THE FACE COULD HAVE LEAD TO POTENTIALLY STOPPING HER BREATHING. THE PT'S PRIMARY CARE PHYSICIAN WAS GOING TO REPORT THIS EVENT TO THE FDA. DR (B)(6) SPOKE TO A MERZ CONTRACTED PHYSICIAN, DR (B)(6) ON (B)(6) 2013. THE PT WAS DISCHARGED WITHOUT EVIDENCE OF A HEART PROBLEM. HE FEELS THE FACIAL SWELLING AND RASH ARE BOTH FROM RADIESSE. WE DISCUSSED THAT THE CARRIER GEL CONTAINS CMC AND GLYCERIN AND THAT THOSE WERE TWO INGREDIENTS THAT SHE SHOULD BE TESTED FOR ALLERGY TO. HE DID NOT HAVE ANY QUESTIONS ABOUT HOW TO TREAT HER NOW; HOWEVER, I OFFERED TO ASSIST IF HE CHANGES HIS MIND. DR (B)(6) THEN SENT AN EMAIL TO DR (B)(6) TO INFORM HIM THAT THE COMPONENTS IN RADIESSE THOUGHT TO BE POSSIBLY, ALTHOUGH RARELY, ALLERGENIC ARE THE GLYCERIN AND CARBOXYMETHYLCELLULOSE IN THE CARRIER GEL. I WOULD ALSO SUGGEST CONSIDERING LIDOCAINE AS A POSSIBILITY AS WELL AS THE MIXTURE OF LIDOCAINE WITH THE ABOVE INGREDIENTS. ON (B)(6) 2013 THE PT CALLED TO ASK ABOUT THE COMPONENTS TO BE ALLERGY TESTED. SHE ALSO DESCRIBED HER REACTION. SHE IS SEEING AN INTERNAL MEDICINE SPECIALIST IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548612 RADIESSE DERMAL FILLER RADIESSE INJECTABLE IMPLANT LMH MERZ NORTH AMERICA, INC. 100065428

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization