BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 3855571 · Received May 28, 2014

    Report

    Report Number
    2135225-2014-00040
    Event Type
    Other
    Date Received
    May 28, 2014
    Date of Event
    April 23, 2014
    Report Date
    May 28, 2014
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR REPORTED RADIESSE LOT NUMBER WAS REVIEWED. ALL REQUIRED INCOMING, IN PROCESS, AND FINAL RELEASE TESTING SPECIFICATIONS FOR THIS LIT WERE MET PRIOR TO RELEASE. NO NON-CONFORMANCES WERE DISCOVERED THAT WOULD HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    DR (B)(6) REPORTED THE FOLLOWING: ON (B)(6) 2014, A FEMALE PT, INITIALS (B)(6), WAS INJECTED WITH RADIESSE INTO THE NLFS, MALAR PADS AND PRE-JOWL SULCUS. THERE WAS NO BRUISING INITIALLY AFTER TREATMENT AND SHE WAS VERY PLEASED. THE FOLLOWING DAY THERE WAS A SMALL BRUISE IN THE PRE-JOWL SULCUS. THE MAJORITY OF THE RADIESSE WAS PUT IN THE MALAR PADS AND THE NASOLABIAL LINES WITH AN EXCELLENT OUTCOME. A SMALL AMOUNT OF RADIESSE WAS INJECTED INTO THE PRE-JOWL SULCUS. THE PT CALLED DR (B)(6) TWO DAYS AFTER TREATMENT SAYING THE "BRUISE WAS GETTING BIGGER." ON THE 3RD DAY POST RADIESSE INJECTION THE REDNESS AND SWELLING STARTED TO SPREAD. ON (B)(6) 2014, IN THE MORNING, DR (B)(6) SAW THE PT AT HIS OFFICE AND SHE HAD POINT TENDERNESS AT THE RIGHT PRE-JOWL SULCUS WITH SKIN CHANGES CONSISTENT WITH COMPRESSION CAUSING EARLY SIGNS OF SKIN NECROSIS DISTAL TO THE COMPRESSION. THERE WERE LITTLE BLISTERS DEVELOPING BY THE CHIN AND THE LOWER LIP. DR (B)(6) GAVE THE PT NITRO PASTE, ASPIRIN, WARM COMPRESSES AND MASSAGE AND 200 UNITS OF CELLULITIS. DR (B)(6) GAVE THE PT BACTROBAN OINTMENT AND AUGMENTIN 875/125MG FOR 10 DAYS AS A PRECAUTION. ON (B)(6) 2014, DR (B)(6) PROVIDED FURTHER INFO. HE INJECTED 0.1CC OF RADIESSE INTO THE PRE-JOWL SULCUS. A TOTAL OF 3CC WAS THE TOTAL VOLUME USED. ON DAY 3 POST INJECTION NITRO PASTE, VITRASE AND ASPIRIN WERE USED. THE NECROSIS STARTED ON DAY 4 GOING INTO DAY 5. ON DAY 5 AND 6 HE BROUGHT THE PT BACK INTO THE OFFICE. THE AREA WAS TENDER POSTERIOR TOWARDS THE BACK OF THE JAW LINE. HE THINKS THAT THIS WAS AN INTRAVASCULAR INJECTION AND BLOOD FLOW BACKED UP BUT NOT WHERE INJECTED. DR (B)(6) STATED THAT HE SAW THE PT ON (B)(6) 2014 AND THE PT HAS TURNED A CORNER (IMPROVED). THERE WERE BLISTERS IN THE LIP AND CHIN. THE PT IS HEALING NOW. HE THINKS THAT THE PT WILL BE HEALED IN A FEW WEEKS. HE STATED, "HOPEFULLY SHE WON'T SCAR." DR (B)(6) STATED THAT AT THE END OF THE PROCEDURE THERE WAS 0.1CC LEFT IN THE SYRINGE. ON (B)(6) 2014, DR (B)(6) PROVIDED F/U INFO. THE PT IS HEALING SLOWLY. THE HEALING PROCESS HAS STARTED. THERE IS DISCOLORATION. ABOUT TWO WEEKS AGO HE STARTED SENDING THE PT TO A DERMATOLOGIST FOR MICRO NEEDLING AND LASER TREATMENTS. HE THINKS THAT IT WILL BE ANOTHER FEW WEEKS BEFORE THE PT IS HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314780 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ NORTH AMERICA, INC. 8071M0K1 100072196

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention 0.75CC OF 1% PLAIN LIDOCAINE (NO EPI).| THE RADIESSE SYRINGES WERE EACH MIXED WITH,