BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 3521357 · Received December 6, 2013

    Report

    Report Number
    2135225-2013-00155
    Event Type
    Other
    Date Received
    December 6, 2013
    Date of Event
    November 5, 2013
    Report Date
    November 8, 2013
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, DR (B)(6) REPORTED TO HER MERZ SALES REP THAT HER PT HAS SWELLING OF NASOLABIAL FOLD/BLANCHING/PUSTULES/PAIN. ON (B)(6) 2013, DR (B)(6) PROVIDED ADD'L INFO: THE PT WAS INJECTED ON MONDAY ((B)(6) 2013) INTO THE MALAR CHEEKS, NLF, RIGHT ANGLE, MARIONETTE LINES MORE RIGHT THAN LEFT. THE PT LEFT THE OFFICE LOOKING GREAT. SHE HAD A SLIGHT SWELLING OF THE RIGHT ANGLE. THIS SWELLING HAS COMPLETELY RESOLVED. THE NEXT DAY THE PT HAD TENDERNESS IN THE RIGHT ALAR. THE PT THOUGHT SHE HAD A BLACKHEAD. SHE SQUEEZED IT AND MANIPULATED IT. THE PT CALLED DR (B)(6) ON (B)(6) 2013. THE AREA WAS BLANCHED (NOT DUSKY). DR (B)(6) INSTRUCTED THE PT TO APPLY NITRO PASTE 2% OINTMENT 2-3 TIMES A DAY. DR (B)(6) PUT THE PT ON A TAPER OF PREDNISONE STARTING AT 30MG. YESTERDAY ((B)(6) 2013) THE PT SENT A PHOTO TO DR (B)(6). THE AREA WAS PUSTULAR AND DUSKY. THE PT HAD ONLY BEEN DOING THE NITRO PASTE ONCE A DAY. DR (B)(6) CALLED THE PT AND TOLD THE PT TO DO WARM COMPRESSES. THAT WAS DONE ONCE. YESTERDAY ((B)(6) 2013). DR (B)(6) SAW THE PT AND THE AREA WAS MILDLY TENDER, PURPLE AND PUSTULAR. DR (B)(6) STARTED THE PT ON KEFLEX 500MG QID (4 TIMES A DAY) FOR 10-14 DAYS AND ASPIRIN 2 TABLET 81MG. ON (B)(6) 2013, DR (B)(6) SPOKE TO A MERZ CONTRACTED PHYSICIAN, DR (B)(6). HE STATED THAT HE SPOKE TO DR (B)(6) AND THAT THE PT HAS A VASCULAR OCCLUSION OF ONE OF THE BRANCHES OF THE FACIAL ARTERY. DR (B)(6) DID NOT SEE PHOTOS OF THE PT. DR (B)(6) ADVISED DR (B)(6) TO ADD VALTREX AND POTENTIALLY HYPERBARIC OXYGEN TO THE CARE SHE HAS NOW. NITRO PASTE IS NOT NECESSARY AT THIS TIME AS ARE THE WARM COMPRESSES. THE DEVICE HISTORY RECORDS FOR THE RADIESSE LOT WERE NOT REVIEWED AS THE LOT NUMBER WAS UNK. ON (B)(6) 2013, DR (B)(6)'S OFFICE WAS CONTACTED TO FIND OUT HOW THE PT IS DOING CURRENTLY. THE PT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633750 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ NORTH AMERICA, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention THE RADIESSE SYRINGE WAS MIXED WITH 0.2CC 2%| PLAIN LIDOCAINE.