BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2577635 · Received May 7, 2012

    Report

    Report Number
    2135225-2012-00050
    Event Type
    Other
    Date Received
    May 7, 2012
    Date of Event
    April 1, 2012
    Report Date
    April 11, 2012
    Manufacturer
    MERZ AESTHETICS, INC
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RADIESSE DEVICE HISTORY RECORDS FOR 1031062 WERE REVIEWED. ALL REQUIRED TESTING SPECIFICATIONS FOR THE LOT WERE MET PRIOR TO RELEASE AND THERE WERE NO ABNORMALITIES NOTED. THE PT WAS PRESCRIBED ANTIBIOTICS AND ANTI-INFLAMMATORY MEDICATIONS AS PRECAUTION. MEDICAL DIRECTOR CONSULT WAS SET UP BY MERZ AESTHETICS FOR DR. (B)(6) WITH DR. (B)(4). AFTER SPEAKING WITH DR. (B)(4), IT WAS DETERMINED THAT THE PT HAD SKIN NECROSIS. DR. (B)(6) IS NOT TREATING THE PT AT THIS TIME; THEY ARE WAITING FOR REDNESS TO LESSEN ON ITS OWN.

    Description of Event or Problem · 1

    A PT INJECTED WITH RADIESSE DERMAL FILLER IN THE NL FOLDS ON (B)(6) 2012. THE MEDIA BECAME CLOGGED AS IT WAS BEING INJECTED BY DR. (B)(6), AND A BLEB OF PRODUCT WAS INJECTED. HE SWITCHED THE NEEDLES, BUT THE SAME OCCURRED ON THE LEFT SIDE. SOME OF THE MEDIA WAS EXPRESSED WITH A Q-TIP. HE ADVISED THE PT TO CONTINUE TO PRESS AND SPREAD OUT THE RADIESSE ON HER OWN. AFTER 1 1/2 WEEKS POST INJECTION (ABOUT (B)(6)) THE PT STILL NOTICED RED LINES ALONG THE NL FOLDS AND VISIBLE WHITE BLEBS ON BOTH SIDES, WHICH HAD BECOME IRRITATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER RADIESSE INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC 1031062

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention