BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 4321070 · Received November 26, 2014

    Report

    Report Number
    2135225-2014-00090
    Event Type
    Other
    Date Received
    November 26, 2014
    Date of Event
    October 24, 2014
    Report Date
    October 29, 2014
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). HE CANNOT APPRECIATE ANY NECROSIS AT THIS POINT. ON (B)(6) 2014 DR (B)(6) SPOKE TO A MERZ FIELD CLINICAL SPECIALIST (FCS). THEY DISCUSSED ANATOMY OF THIS AREA AS WELL AS PROTOCOL FOR VASCULAR OCCLUSION. DR (B)(6) IS GOING TO SLOW AND/OR STOP THE NITROPASTE AS HE IS CONCERNED THAT IT IS IRRITATING THE OPEN, RAW AREAS OF THE AFFECTED AREA AND CAUSING SOME OF HER DISCOMFORT BUT WILL CONTINUE EVERYTHING ELSE. ON (B)(6) 2014 DR (B)(6) CALLED THE MERZ FCS WITH AN UPDATE FOR THE PT. HE STATES, THE REA IS LOOKING AS IT IS IMPROVING AND PT REPORTS PAIN IS NEARLY GONE BUT ATTRIBUTES IT TO THE OPEN AREA. HE REPORTS THAT THE AREA BLEEDS VERY WELL UPON JUST GENTLY TOUCHING IT WITH A 4X4. SHE HAS BEEN ON ANTIBIOTICS (KEFLEX) FOR 8 DAYS NOW (HE INFORMED THE MERZ FCS THAT HE OPERATED ON THE PT'S BREASTS AT THE SAME TIME AND THAT IS WHY SHE HAS BEEN ON ANTIBIOTICS). TOMORROW IS THE LAST DAY FOR HER MEDROL DOSE PACK AS WELL. HE IS GOING TO ONLY HAVE HER APPLY THE NITROBID TO THE AREAS AROUND THE WOUND FOR TODAY AND THEN STOP THAT AS WELL. ON (B)(6) 2014 DR (B)(6) SPOKE TO A MERZ MEDICAL DIRECTOR, DR (B)(6). DR (B)(6) REVIEWED THE NEED FOR A MOVING NEEDLE WHILE INJECTING IN THE SUBCUTANEOUS PLANE. I REVIEWED THE VASCULAR ANATOMY THAT HE APPEARED ALREADY FAMILIAR WITH. I SUGGESTED DISCONTINUING THE NITROPASTE, VIAGRA, AND MUPIROCIN OINTMENT. I SUGGESTED TWICE DAILY SHOWERING AND KEEPING THE AREA MOIST WITH AQUAPHOR OINTMENT. CONTINUE HER VALTREX AND ORAL ANTIBIOTICS. AVOID EXPOSURE TO HIGH OR LOW TEMPERATURES. ON (B)(6) 2014 DR (B)(6) SPOKE TO DR (B)(6) AT DR (B)(6) REQUEST. DR (B)(6) REASSURED HIM. ALSO ADVISED HIM NOT TO PERFORM ANY REVISIONAL SURGERY ONLY USE OF TOPICAL SCAR GEL, POTENTIAL FRACTIONATED ERBIUM AND OR INTRALESIONAL STEROIDS TO MODULATE SCAR TISSUE IF NECESSARY.

    Description of Event or Problem · 1

    ON (B)(6) 2014 DR (B)(6) INJECTED THE PT IN THE MIDFACE, NLF, ML USING TWO 1.5CC SYRINGES OF RADIESSE. THE PT DID NOT CONTACT DR (B)(6) UNTIL ON (B)(6) 2014. THE PT TOLD DR (B)(6) THAT SHE FELT FINE WHEN SHE LEFT HIS OFFICE BUT TOLD HIM THE PAIN BEGAN ON (B)(6) 2014. THE PT TOOK A PHOTO OF AN AREA THAT APPEARED WHITE. THE PT SPENT ALL WEEKEND ICING THE AREA CONTINUOUSLY AND SPENT MUCH OF SUNDAY OUT IN THE COLD WINDY TEMPERATURES AT A FOOTBALL GAME. SHE THOUGHT SHE MAY HAVE AN INFECTION AND WAS APPLYING NEOSPORIN OINTMENT TO THE AFFECTED AREAS THROUGH THE WEEKEND AND THEN APPLIED MAKEUP TO THE AREA ON (B)(6) 2014. WHEN DR (B)(6) SAW THE PT ON (B)(6) 2014 THE RIGHT NLF FROM THE CORNER OF HER MOUTH EXTENDING UP ALONG HER NOSE TO NEARLY THE CORNER OF HER EYE WAS RAW, RED AND BLISTERY REPORTS DR (B)(6). HE IMMEDIATELY GAVE HER AN IM INJECTION OF STEROID, STARTED HER ON ASPIRIN, VIAGRA, ANTIBIOTICS, ANTIVIRALS AND PO STEROIDS, AND INSTRUCTED TO APPLY NITROPASTE Q2 HOURS AS WELL AS WARM COMPRESSES Q2 HOURS. HE SAW HER BACK ON (B)(6) 2014 AND STATES THAT SHE LOOKS TO BE IMPROVING BUT THE AREA LOOKS TO BE IMPROVING BUT THE AREA LOOKS SOMEWHAT DUSKY/GRAY AT THIS POINT AND SHE IS STILL COMPLAINING OF PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769651 RADIESSE DERMAL FILLER RADIESSE INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention