BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 3413951 · Received October 9, 2013

    Report

    Report Number
    2135225-2013-00100
    Event Type
    Other
    Date Received
    October 9, 2013
    Date of Event
    September 6, 2013
    Report Date
    September 13, 2013
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(4) 2013, (B)(4), PA, MERZ NORTH AMERICA, INC. SPOKE TO DR (B)(6). THIS IS ONE OF HIS EMPLOYEES THAT HE INJECTED IN THE CHEEK AREA. HE USED A VARIETY OF TECHNIQUES TO INCLUDE DERMASCULPTING AND BOLUSES ON PERIOSTEUM USING ASEPTIC TECHNIQUE. HE STATES THE SWELLING STARED 1 WEEK POST AND TENDERNESS STARTED 2 WEEKS POST, STARTING ON THE LEFT CHEEK AND NOW IS THE RIGHT AS WELL, ALTHOUGH L > R. HE REPORTS THE SWELLING TO BE THROUGHOUT THE ENTIRE CHEEK AND REPORTS THE PT SAYS THE TENDERNESS IS MORE LATERAL ON BOTH CHEEKS. HE IS UNSURE IF SHE HAD AN INFECTION SOMEWHERE AT THE TIME OF INJECTION. HE STATES HE DID SOME BLOOD TESTS TO R/O INFECTON AND STARTED HER ON KEFLEX 500MG, BACTRIM DS AND SOLUMEDROL YESTERDAY. HER SKIN IS NOT WARM, NO FEVER AT THIS POINT AND NO SKIN ERYTHEMA, NO OPEN WOUND. NO SIGNS OF POSSIBLE VASCULAR ISSUE. SHE DID NOT HAVE BRUISING POST INJECTION. HE REPORTS THAT SHE DOES HAVE SOME ACNE AND HAD AN ACNE TREATMENT THE SAME DAY AT THE INJECTIONS AND A CHEMICAL PEEL A WEEK AFTER. WE DISCUSSED POSSIBILITIES OF INFECTION DUE TO DOUBLE TREATMENTS. WE ALSO DISCUSSED HEAD OF BED ELEVATION AND COOL COMPRESSES FOR COMFORT. ON (B)(6) 2013, DR (B)(6) PROVIDED THE UPDATE THAT THE PT GOT ANTIBIOTICS AND STEROIDS. AFTER THAT SHE GOT BETTER. THE PT CAME IN FOR F/U A FEW DAYS LATER (AFTER (B)(6) 2013). THE DEVICE HISTORY RECORD FOR THE REPORTED RADIESSE LOT WAS REVIEWED. ALL REQUIRED INCOMING, IN PROCESS, AND FINAL RELEASE TESTING SPECS 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 WITH RADIESSE. ON (B)(6) 2013, THE PT COMPLAINED OFF SWELLING. ON (B)(6) 2013, THE PT COMPLAINED OF TENDERNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513022 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ NORTH AMERICA, INC. 100065969

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention THE RADIESSE SYRINGE WAS MIXED WITH,| 0.4CC OF 2% LIDOCAINE