BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2181537 · Received July 14, 2011

    Report

    Report Number
    2135225-2011-00063
    Event Type
    Other
    Date Received
    July 14, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 21, 2011
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS FOR LOT 1023482 WERE REVIEWED, ALL REQUIRED TESTING SPECS WERE MET PRIOR TO RELEASE, THERE WERE NO ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    THIS COMPLAINT WAS FORWARDED BY (B)(6), SECTION HEAD MEDICAL DEVICES / SAFETY OFFICER, DRUG REGULATORY AFFAIRS AT (B)(4). THE COMPLAINT ORIGINATED IN (B)(6). A (B)(6) FEMALE PT WAS INJECTED WITH 0.5 CC RADIESSE INTO NOSE AND GLABELLA, AND ON (B)(6) 2011, THE DISCHARGE CAN BE SEEN FROM THE AREA. TWO PT PHOTOS WERE ALSO FORWARDED TO MERZ AESTHETICS. THIS PT WAS TRANSFERRED TO DR (B)(6) ON (B)(6) 2011 FOR TREATMENT PER PT'S REQUEST. DR (B)(6) PROVIDED ADDITIONAL INFO: "THIS IS CONSIDERED AS SKIN NECROSIS CAUSED BY THE OBSTRUCTION OF BLOOD VESSEL IN SUBDERMIS." THE PT WAS ADMINISTERED ANTIBIOTICS, NAME, ROUTE AND DOSE WERE NOT PROVIDED; WET DRESSING, BETADINE SOAKING, AND PROSTAGLANDIN I.V. INJECTION. PER DR (B)(6), THE AREA "DOES NOT LOOK SEVERE CURRENTLY, IT IS EXPECTED TO BE SUBSIDED SOON." AN UPDATE ON PT'S RECOVERY STATUS WAS REQUESTED ON (B)(6) 2011 BUT NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER RADIESSE INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC. 1023482

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other