BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 3430339 · Received October 17, 2013

    Report

    Report Number
    2135225-2013-00103
    Event Type
    Other
    Date Received
    October 17, 2013
    Date of Event
    September 16, 2013
    Report Date
    September 16, 2013
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORD FOR THE REPORTED RADIESSE LOT 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

    THE PT WAS INJECTED ON (B)(6) 2013 IN THE NFLS AND LEFT THE OFFICE. AFTER ABOUT 20 MINUTES THE PT PHONED TO STATE THAT THERE WAS SEVERE SWELLING. THE PT WENT TO THE WALK-IN CLINIC, WAS ASSESSED AND WAS TRANSFERRED TO THE ER. THE RADIESSE WAS MIXED WITH AN UNKNOWN AMOUNT OF LIDOCAINE. THE PT WAS ALSO INJECTED WITH BOTOX. DR (B)(6), INJECTOR SPOKE TO A MERZ NORTH AMERICA, INC NURSE, (B)(4), RN, BSN ON (B)(6) 2013. DR (B)(6) STATED THAT THE PT PHONED THE OFFICE 20 MINUTES AFTER LEAVING THE OFFICE STATING SHE HAD SEVERE SWELLING OF THE LIPS AND EYES. SHE WAS REFERRED TO URGENT CARE WHERE SHE WAS SUBSEQUENTLY TRANSFERRED TO THE ER. DR (B)(6) AND (B)(4) DISCUSSED POSSIBLE ETIOLOGIES SUCH AS: C1 ESTRACE DEFICIENCY, SULFITE ALLERGY TO THE LIDOCAINE PRESERVATIVE, TOPICAL ALLERGY, LATEX ALLERGY, CMC ALLERGY, CONCOMITANT TREATMENTS, AND/ OR IGE MEDIATED RESPONSE. DR (B)(6) STATES THIS IS THE FIRST TIME THE PT HAS EVER HAD RADIESSE. ON (B)(6) 2013, (B)(6), RN FOR DR (B)(6)REPORTED THAT THE PT WAS HOSPITALIZED FOR ANAPHYLAXIS. ON (B)(6) 2013, DR (B)(6) SPOKE TO A MERZ NORTH AMERICA, INC CONTRACTED PHYSICIAN, DR (B)(6). ACCORDING TO DR (B)(6) THE PT WAS HOSPITALIZED WITH "RECURRENT ANAPHYLAXIS". DR (B)(6) AND DR (B)(6) BOTH AGREED THAT THIS WAS AN UNLIKELY DIAGNOSIS. DIFFERENTIAL DIAGNOSIS INCLUDED PANIC ATTACKS, ANGIOEDEMA. SHE HAD ALREADY CONSULTED WITH AN ALLERGIST. ON (B)(6) 2013, (B)(6) , RN PROVIDED THE FOLLOWING INFO: THE PT WAS IN ICU FOR TWO DAYS. THEY DO NOT HAVE DATA PROVIDED BY THE HOSPITAL. THE PT WAS GIVEN IV STEROIDS IN THE HOSPITAL. FROM DR (B)(6) NOTES, ALLERGIC REACTION AND ANAPHYLAXIS WERE THE REASONS FOR THE TWO DAYS IN ICU. THE HOSPITAL SUSPECTS THAT IT WAS RADIESSE. BOTOX WAS GIVEN AT THE SAME TIME. THE PT RESOLVED IN TWO DAYS. THE PT STILL HAS A PROBLEM WITH ITCHING. SHE IS SEEING AN ALLERGIST. DR (B)(6) IS THE PT'S ALLERGIST. HIS OFFICE WAS CONTACTED ON (B)(6) /2013, BUT HAS NOT YET PROVIDED INFO IF RADIESSE ALLERGY TESTING WILL BE PERFORMED FOR THIS PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531986 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ NORTH AMERICA, INC. 100064951

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization BOTOX| THE AMOUNT IS UNK| THE RADIESSE SYRINGE WAS MIXED WITH LIDOCAINE,