BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2974237 · Received February 13, 2013

    Report

    Report Number
    2135225-2013-00015
    Event Type
    Other
    Date Received
    February 13, 2013
    Date of Event
    November 1, 2012
    Report Date
    January 22, 2013
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON 01/24/2013 THE FOLLOWING UPDATES WERE REPORTED IN A WRITTEN REPORT BY THE PHYSICIAN: THE PATIENT WAS INJECTED WITH 1.5 CC OF RADIESSE DURING (B)(6) 2012. THE PATIENT AFTER 3 DAYS PRESENTED AN AREA OF HEMATOMA WITH ECCHYMOSES, PROBABLE VASCULITIS, WITH COMPLETE PARALYSIS OF THE FACIAL NERVE IN ORBICULAR AND LIP AREA. COMPRESSION OF THE TRIGEMINAL NERVE AND AREA OF NECROSIS IN CHEEK. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME. THE LOT NUMBER WAS NOT PROVIDED BY THE INJECTOR THEREFORE FURTHER REVIEW WAS NOT PERFORMED.

    Description of Event or Problem · 1

    PATIENT INJECTED RADIESSE DEVELOPED SWELLING, FACIAL PARALYSIS AND NECROSIS OF THE AREA 3 DAYS POST-INJECTION. THE PATIENT WAS TAKING ASPIRIN; DOSE UNKNOWN. PATIENT GENDER WAS NOT REPORTED. FURTHER PATIENT AND EVENT INFORMATION WILL BE PROVIDED BY THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64317 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other ASPIRIN (DOSE UNK)| ANTIHYPERTENSIVE (LOSARTAN)