BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 3109325 · Received May 8, 2013

    Report

    Report Number
    2135225-2013-00046
    Event Type
    Other
    Date Received
    May 8, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 13, 2013
    Manufacturer
    MERZ AESTHETICS INC
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS FOR RADIESSE WERE NOT REVIEWED AS THE LOT NUMBER WAS UNK. THE PT IS SCHEDULED TO SEE THE PLASTIC SURGEON FOR ADDITIONAL THREE WEEKS.

    Description of Event or Problem · 1

    THE PT WAS INJECTED WITH RADIESSE INTO CHEEKS BY DR (B)(6). SHE EXPERIENCED IMMEDIATE SWELLING AND BY NEXT DAY, HER LEFT CHEEK BECAME BLUE. SHE HAS BLISTERS THAT ARE PEELING AND SKIN FALLING OFF. SHE STATED SHE DOES NOT KNOW IF THERE IS AN INFECTION IN THE AREA; SHE IS TAKING ANTIBIOTICS. SHE STATES SHE WILL BE SEEING A PLASTIC SURGEON, NAME NOT PROVIDED. ON (B)(6) 2013, THE PT STATED SHE HAS BEEN SEEING A PLASTIC SURGEON; NAME NOT PROVIDED. HER SKIN ON LEFT CHEEK AND FOREHEAD IS "SLOUGHING OFF, TWO LAYERS NOW." THERE IS A SMALL NECROTIC AREA STILL REMAINING BY HER LEFT NASOLABIAL FOLD. HER PLASTIC SURGEON HAD BEEN TREATING HER FOR VASCULAR OCCLUSION, NECROSIS AND INFECTION WITH NITROPASTE, PROCARDIA, MEDROL DOSE PACK AND ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202188 RADIESSE DERMAL FILLER RADIESSE INJECTABLE IMPLANT LMH MERZ AESTHETICS INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention