BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 3082808 · Received April 23, 2013

    Report

    Report Number
    2135225-2013-00036
    Event Type
    Other
    Date Received
    April 23, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 28, 2013
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS FOR RADIESSE LOT 1036550 WERE REVIEWED. ALL REQUIRED TESTING SPECS WERE MET PRIOR TO RELEASE, THERE WERE NO ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    THIS ADVERSE EVENT WAS REPORTED BY (B)(6), (B)(6) AT THE FACILITY ON (B)(6) 2013. SHE WAS INJECTED BY DR (B)(6) WITH RADIESSE ON (B)(6) 2013 INTO NASOLABIAL FOLDS AND CHEEKS. SHE HAS A POSSIBLE ANGULAR ARTERY OCCLUSION MANIFESTED BY THE FOLLOWING SYMPTOMS: RIGHT SIDE OF NOSE SWOLLEN, MOTTLED (DUSKY RED), AND TENDER. SHE ALSO HAS A CLEAR DISCHARGE FROM HER RIGHT NOSTRIL. THERE IS NO FEVER, NO INFECTION, NO SKIN SURFACE DISCHARGE, NO SKIN BREAKDOWN. SHE SELF-TREATED WITH WARM COMPRESSES. ON (B)(6) 2013, (B)(6) CONSULTED WITH MERZ AESTHETICS, INC. RN. THEY DISCUSSED THE PROBABILITY OF VASCULAR EVENT AS SHE REMAINS MOTTLED TODAY AND EXQUISITELY TENDER TO THE AFFECTED AREA. SHE HAS CULTURED THE NASAL DRAINAGE BUT WE DISCUSSED THIS IS UNLIKELY SECONDARY TO INFECTIOUS PROCESS AT THIS TIME, BUT MORE DUE TO INFLAMMATION AT THE SITE. DR (B)(6) PROVIDED HER WITH THE VASCULAR CRASH CART ARTICLE AS WELL AS RX FOR NITROPASTE, DOXYCYCLINE AND ASA; ALSO ADVISED HER TO MESSAGE AND APPLY WARM PACKS TO THE AREA. THEY DISCUSSED THAT MESSAGE SHOULD BE VIGOROUS/VIBRATORY, IF SHE CAN TOLERATE IT, IN ORDER TO INCREASE BLOOD SUPPLY TO THE AREA AS WELL AS TO MOVE ANY POSSIBLY COMPRESSIVE PRODUCT AT THE INJECTION SITE. THEY FURTHER DISCUSSED THE LIKELY PROGRESSION OF HER SYMPTOMS AND WHAT SHE CAN DO TO ASSIST - MVI, WOUND SUPPORT. HYPERBARIC, LASERS, ETC. ON (B)(6) 2013, (B)(6) STATED ALL OF HER EVENTS RESOLVED, SHE IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175170 RADIESSE DERMAL FILLER RADIESSE INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC. 1036550

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other| R 0.3 CC OF 2% LIDOCAINE MIXED WITH RADIESSE