BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2974244 · Received February 14, 2013

    Report

    Report Number
    2135225-2013-00021
    Event Type
    Other
    Date Received
    February 14, 2013
    Date of Event
    October 26, 2012
    Report Date
    November 12, 2012
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE: 05/2013. MANUFACTURING DATE: 05/2011. (B)(4). INFO PROVIDED BY (B)(6), RN, BSCN FIELD CLINICAL SPECIALIST (B)(6): THE PT DID NOT SEE, SPEAK OR CONSULT THE CLINIC'S MEDICAL DIR AT ALL UNFORTUNATELY WHEN THE EVENT OCCURRED. THE PT WENT TO A WALK IN CLINIC TO GET A PRESCRIPTION FOR ANTIBIOTICS. I JUST SPOKE TO THE PT ((B)(6) 2013) (HE IS THE CLINIC MGR) AND HE SAID HE DID NOT F/U WITH THE DOCTOR AND CANNOT REMEMBER THE PHYSICIAN'S NAME, AS IT WAS HIS FIRST TIME MEETING THIS PHYSICIAN. SINCE THE EVENT, THE SITE HAS HEALED AND HE HAS NO COMPLAINTS OR FURTHER ISSUES. THE DEVICE HISTORY RECORDS FOR REPORTED LOTS WERE REVIEWED. ALL REQUIRED TESTING SPECIFICATIONS WERE MET PRIOR TO RELEASE, THERE WERE NO ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    THE PT (MGR AT (B)(4)) WAS INJECTED DURING A RADIESSE TRAINING. THE PT WAS INJECTED WITH 2X 1.5 CC (LOT NUMBER 1033527) AND 1 X 0.8 CC (LOT NUMBER 1026814) TO CHEEKS AND JAWLINE CONTOURING ON (B)(6) 2012. PT WAS INJECTED BY (B)(6) FCS ON THE LEFT SIDE OF THE FACE, AND HAD NO REPORTED ISSUES. THE RIGHT SIDE WAS INJECTED BY THE RN IN TRAINING, WHICH THE PT COMPLAINED "THE PRODUCT MIGRATED AS IT WASN'T INJECTED DEEP AND CREATED AN ABSCESS OR MAYBE I REACTED TO THE LIDOCAINE". AS PER THE PT, "THE PRODUCT WAS FINE THE NEXT DAY, BUT IT WAS 2 DAYS LATER WHEN I SAW A 'PIMPLE-LIKE' BUMP UNDERNEATH THE CHEEK HOLLOWS (NO RADIESSE WAS INJECTED IN THIS AREA) WHERE I THINK THE PRODUCT MOVED TO AND SO I TRIED TO SQUEEZE IT AND SEE IF ANYTHING CAME OUT, BUT NOTHING DID. THE NEXT MORNING MY ENTIRE RIGHT SIDE OF THE FACE WAS SO SWOLLEN UP TO MY EYES. I HAD TO GET ANTIBIOTICS FROM MY FAMILY DOCTOR. BECAUSE IT WAS HALLOWEEN, I EVEN WORE FULL-FACE MAKEUP." FCS ASKED IF THE SKIN WAS BROKEN OR OPEN AT THE SIDE OF THE ABSCESS BECAUSE HE SAID APPLIED MAKEUP ON TOP, AND THE PT SAID NO. THE RN (B)(6) WHO WAS WORKING AT THE CLINIC SAW THE PT EVERYDAY POST INJECTION AND TOLD FCS THAT HE HAD TO "EXCISE THE BUMP WITH A NEEDLE TO DRAIN THE FLUID AND IT WAS DEFINITELY INFECTED. HE (THE PT) ALSO USED A SAFETY PIN TO TRY AND DRAIN THE FLUID AT HOME BEFORE I TRIED TO DRAIN IT." THIS PART WAS ONLY DISCLOSED BY THE RN AND NOT TO THE PT. FCS ASKED BOTH RN AND PT IF THE MEDICAL DIR WAS CONSULTED WITH THIS EVENT AND THEY SAID NO. UPON ASSESSMENT (3 WEEKS POST INJECTIONS), PT'S EDEMA STILL SLIGHTLY PRESENT BUT IS HEALING WELL, WITH NO SIGNS OF FURTHER INFECTION. PT COMPLETED ANTIBIOTICS PO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66186 RADIESSE DERMAL FILLER RADIESSE INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC. 1033527/1026814

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention