BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 3844636 · Received May 14, 2014

    Report

    Report Number
    2135225-2014-00033
    Event Type
    Other
    Date Received
    May 14, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 5, 2014
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THEY ALSO DISCUSSED POSSIBLE OTHER ALLERGIC COMPONENTS SUCH AS THE SULFITE PRESERVATIVE IN THE LIDOCAINE. C1 ESTERASE DEFICIENCY WAS ALSO DISCUSSED. THE PATIENT IS NOW FULLY RECOVERED. THE DEVICE HISTORY RECORDS FOR THE REPORTED LOT WERE REVIEWED. ALL REQUIRED INCOMING, IN PROCESS, AND FINAL RELEASE TESTING SPECIFICATIONS FOR THIS LOT WERE MET PRIOR TO RELEASE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, DR (B)(6) REPORTED THAT A PATIENT DEVELOPED SWELLING AND HAD AN ANAPHYLACTIC REACTION, MANIFESTED AS HOARSENESS IN VOICE, ABOUT ONE HOUR POST-RADIESSE INJECTION. THE PATIENT WAS INSTRUCTED TO TAKE BENADRYL AND TO GO TO THE EMERGENCY ROOM (ER). THE PATIENT WAS HOSPITALIZED AND TREATED WITH SOLUMEDROL, 60 MG IV AND AN EPINEPHRINE INJECTION. PATIENT WAS RELEASED FROM HOSPITAL THE NEXT DAY WITH ORAL STEROID FOR 5 DAYS. ON (B)(6) 2014, DURING MEDICAL CONSULTATION WITH (B)(4) RN AT MERZ, NORTH AMERICA, INC., DR. (B)(4) REVIEWED THE INFORMATION REGARDING A PATIENT, SHE INJECTED ON (B)(6) 2014 WITH 1.5CC OF RADIESSE TO THE ML AND THE PJS. DR. (B)(6) STATED THAT ONE HOUR POST INJECTION OF THE PATIENT CALLED THE OFFICE STATING THAT SHE HAD SWELLING AND HER VOICE WAS HOARSE. DR. (B)(6) FELT THE PATIENT MAY BE IN RESPIRATORY DISTRESS AND RECOMMENDED THE PATIENT SEEK TREATMENT AT THE ER. THE PATIENT WAS GIVEN IV SOLUMEDROL AND EPINEPHRINE AND WAS ADMITTED OVERNIGHT FOR OBSERVATION. DR. (B)(6) AND (B)(4) DISCUSSED, THAT ALTHOUGH RARE, THERE IS A RISK OF ALLERGIC REACTION RELATED TO THE GLYCERIN OR THE CMC GEL CARRIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288730 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ NORTH AMERICA, INC. 100072192

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization 0.5 CC LIDOCAINE,| NO EPINEPHRINE, WAS MIXED WITH RADIESSE