BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 3170512 · Received June 5, 2013

    Report

    Report Number
    2135225-2013-00073
    Event Type
    Other
    Date Received
    June 5, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 20, 2013
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS FOR RADIESSE WERE NOT REVIEWED AS THE LOT NUMBER WAS UNKNOWN BY THE INJECTOR.

    Description of Event or Problem · 1

    DR (B)(6) INJECTED A FEMALE PATIENT WITH ONE 1.5 CC RADIESSE SYRINGE INTO CHEEKS. AFTER INJECTION, THE RIGHT UPPER CHEEK BLANCHED UP. DR (B)(6) STARTED PATIENT ON NITROPASTE. PATIENT DEVELOPED A HEADACHE AND DR (B)(6) STOPPED THE NITROPASTE. BLANCHING RESOLVED. PATIENT DEVELOPED A SMALL HEMATOMA. THE NEXT DAY, PATIENT REPORTED BRUISING IN THE AREA. ON DAY 6 POST INJECTION, THE PATIENT ADDED VASELINE TO VESICLES THAT SHE OBSERVED ON THE RIGHT MARIONETTE LINE NEAR THE JAWLINE AND MEDIAL CHEEK AND BELOW RIGHT EYELID; THIS AREA IS AT LEAST 3CM ABOVE THE INJECTED AREA. DR (B)(6) SUSPECTED A HERPETIC OUTBREAK. ON (B)(6) 2013, (B)(4), RN AT AT MERZ AESTHETICS, SPOKE WITH DR (B)(6) REGARDING A PATIENT THAT WAS INJECTED WITH 0.9 CC OF RADIESSE MIXED WITH 0.3CC OF 1% LIDOCAINE WITH EPI ON (B)(6) 2013. DR (B)(6) STATED THAT UPON INJECTION, THE RIGHT MIDFACE BLANCHED ALONG WITH THE RIGHT NLF AND RIGHT UPPER LIP REGION. HE IMMEDIATELY APPLIED NITRO PASTE; HOWEVER, THE PATIENT C/O OF A HEADACHE FROM THE NITRO PASTE, HE REMOVED IT FROM THE SKIN. UPON REMOVING THE NITRO PASTE, HE STATED THE AREA HAD "PINKED UP". THE PATIENT STATED SHE HAD TENDERNESS OF THE RIGHT MIDFACE POST INJECTION. ON (B)(6) 2013, THE PATIENT BEGAN TO DEVELOP SMALL CLEAR VESICLES WITH A YELLOWISH SECRETION FROM THE VESICLES. THE PATIENT DID NOT CONTACT DR (B)(6) AND SELF TREATED BY APPLYING VASELINE TO THE LESIONS. SHE CALLED THE OFFICE ON (B)(6) 2013 TO REPORT THE LESIONS AND DR (B)(6) SAW HER IMMEDIATELY IN THE OFFICE. ON (B)(6) 2013 AT 1837 EST DR (B)(6) FORWARDED PATIENT PHOTOS TO (B)(4). THE PHOTOS SHOW THE PATIENT PRESENTS WITH ERYTHEMA FROM THE RIGHT LOWER EYELID TO JUST SUPERIOR TO THE RIGHT ORAL COMMISSURE. THERE ARE DIFFUSE VESICLES WITHIN THIS REGION AND EXTENDING TO THE RIGHT ML REGION. THE PATIENT HAS ONE VESICLE IN THE MOST INFERIOR ASPECT OF THE SUBMALAR REGION. ON THE SAME DAY, (B)(4) SPOKE WITH DR (B)(6) AGAIN. DR (B)(6) PRESCRIBED VALTREX FOR ANTIVIRAL AND KEFLEX AS AN EMPIRICAL ANTIBIOTIC TO COVER POSSIBLE SECONDARY SKIN INFECTION. HE ALSO HAD THE PATIENT DISCONTINUE VASELINE AND BEGIN APPLYING BACITRACIN. DR (B)(6) STATES THE DIFFERENTIAL DIAGNOSIS OF POSSIBLE VASCULAR OCCLUSION WITH SECONDARY HERPETIC OUTBREAK. HE STATES UPON QUESTIONING THE PATIENT PROVIDED PREVIOUS HISTORY OF COLD SORES. DR (B)(6) ALSO STATED THAT THIS PATIENT CONSTANTLY TOUCHES AND "PICKS AT" HER FACE. WE DISCUSSED THE POSSIBILITY THAT THE PATIENT HAS SPREAD THE HERPETIC LESIONS BY CONSTANT HAND TO FACE CONTACT. THEY DISCUSSED VASCULAR OCCLUSION VERSES HERPETIC OUTBREAK AND SUPPORTIVE MEASURES OF OTHER HCPS SUCH AS LOCALIZED WOUND CARE AND GOOD NUTRITIONAL SUPPORT. DURING A FOLLOW-UP CALL, PER DR (B)(6), THE PATIENT IS RECOVERING NICELY; HOWEVER, SMALL AMOUNT OF REDNESS IS STILL PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249236 RADIESSE DERMAL FILLER RADIESSE INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention RADIESSE| 0.3 CC OF 1% LIDOCAINE WITH EPINEPHRINE MIXED WITH