BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE VOICE GEL

    MDR report key: 2634178 · Received June 20, 2012

    Report

    Report Number
    2135225-2012-00058
    Event Type
    Other
    Date Received
    June 20, 2012
    Date of Event
    May 24, 2012
    Report Date
    June 19, 2012
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    MIX
    PMA / PMN Number
    K060815
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE NOT REVIEWED AS THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THIS COMPLAINT WAS E-MAILED TO MERZ AESTHETICS, INC. BY PATIENT'S DAUGHTER. SHE WROTE THAT HER MOTHER WAS INJECTED WITH RADIESSE VOICE GEL INTO LEFT VOCAL FOLD ON (B)(6) 2012, FOR A PARALYZED LEFT VOCAL FOLD FOLLOWING LEFT LUNG REMOVAL. THREE DAYS LATER, SHE FELT WEAK AND HAD A NEED TO COUGH. TWO WEEKS LATER, SHE HAS A FEVER, COUGH, AND UNCONTROLLED TACHYCARDIA/A-FIB, UNABLE TO CARDIOVERT. A CT SCAN REVEALED A "NODULE" IN HER REMAINING LUNG OF 6MM WHICH WAS NOT THERE TWO MONTHS AGO WHEN THEY FOUND THE LEFT LUNG CANCER. ON (B)(6) 2012, PATIENT'S DAUGHTER PROVIDED ADDITIONAL INFORMATION. HER MOTHER IS NOW HOSPITALIZED AS OF (B)(6) 2012, FOR UNCONTROLLED TACHYCARDIA/ATRIAL FIBRILLATION. SHE STATED THE DOCTORS WERE SUPPOSED TO "CARDIOVERT WITH PADDLES" BUT DECIDED TO WAIT AND ATTEMPT TO CONTROL EVENTS WITH MEDICATIONS. THE PATIENT IS TAKING CARDARONE AND HEPARIN. THE PATIENT ALSO HAS FEVER AND IS COUGHING. THE NODULE IN THE RIGHT LUNG LOBE WILL BE EXAMINED FURTHER ONCE THE PATIENT IS STABLE. AT THIS TIME, IT IS UNKNOWN IF THE NODULE IS CANCER OR RADIESSE VOICE GEL. PER PATIENT'S DAUGHTER, DR. (B)(6) WAS THE RADIESSE VOICE GEL INJECTING PHYSICIAN. ON (B)(6) 2012, DR. (B)(6) STATED THAT HE DOES NOT AGREE THAT RADIESSE VOICE GELL CAUSED ANY OF THE PATIENT'S ADVERSE EVENT. NO OTHER INFORMATION WAS PROVIDED. ON (B)(6) 2012, PATIENT'S DAUGHTER STATED HER "MOTHER-IN-LAW" IS OUT OF A-FIB, IS ON MEDICATION, NAME NOT PROVIDED; SHE IS STILL IN THE HOSPITAL, NOW HAS "STOMACH TROUBLES;" THE HEART IS "OK." AS OF (B)(4) 2012, DESPITE SEVERAL ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, NONE WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE VOICE GEL RADIESSE INJECTABLE IMPLANT MIX MERZ AESTHETICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization