BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2111506 · Received May 20, 2011

    Report

    Report Number
    2135225-2011-00033
    Event Type
    Other
    Date Received
    May 20, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 11, 2011
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT'S SYMPTOMS HAD RESOLVED AT THE TIME THIS EVENT WAS REPORTED TO MERZ AESTHETICS. DR (B)(6) REQUESTED INFO ABOUT THE COMPOSITION OF RADIESSE AND REQUESTED A SAMPLE FOR ALLERGY SKIN TESTING. DR (B)(6) PLANS TO TEST THE PT FOR RADIESSE ALLERGY STARTING ON (B)(6). A F/U REPORT IS EXPECTED, WITH RESULTS FROM THE RADIESSE ALLERGY TESTING. SINCE DR (B)(6) WAS NOT THE RADIESSE INJECTOR, THE INJECTION DETAILS ARE NOT AVAILABLE, I.E. RADIESSE LOT NUMBER, AMOUNT INJECTED, AREAS INJECTED OR INJECTION DATE.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT HAD BEEN INJECTED WITH RADIESSE DERMAL FILLER; FACIAL AREAS NOT IDENTIFIED AND DATE OF INJECTION IS UNK, BUT OCCURRED IN 2011. AT 7 DAYS POST INJECTION, THE PT DEVELOPED SEVERE FACIAL EDEMA. THE PT WAS HOSPITALIZED FOR ONE WEEK, TREATED WITH ANTIBIOTICS, AND THE EDEMA RESOLVED. TREATING PHYSICIAN, DR (B)(6), INDICATED THAT HE FEELS THIS PT HAD AN ALLERGIC REACTION, NOT CELLULITIS AS HOW SHE HAD BEEN TREATED. THE PT DID HAVE A FEVER (AFEBRILE) AND HAD A NORMAL WHITE BLOOD CELL COUNT. DR (B)(6) REQUESTED INFO ABOUT THE COMPOSITION OF RADIESSE; WHICH WAS PROVIDED TO HIM ON (B)(6) 2011.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization