BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 5068384 · Received September 10, 2015

    Report

    Report Number
    2135225-2015-00065
    Event Type
    Injury
    Date Received
    September 10, 2015
    Date of Event
    August 12, 2015
    Report Date
    August 21, 2015
    Manufacturer
    MERZ NORTH AMERICA
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE PHYSICIAN'S CLINICAL OPINION, THIS CASE WAS ASSESSED AS REPORTABLE TO THE FDA AS THE EVENT WAS DEEMED TO MEET SERIOUS INJURY CRITERIA OF NECESSITATING MEDICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. ADDITIONALLY, THE PHYSICIAN ASSESSED THAT THE DEVICE WAS POSSIBLY CAUSING OR CONTRIBUTING TO THE EVENT. THE DEVICE HISTORY RECORD REVIEW FOR THE REPORTED LOT WAS CONDUCTED. NO NON-CONFORMANCES WERE DISCOVERED THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THAT A (B)(6) FEMALE RECEIVED RADIESSE INJECTIONS TO HER NASAL LABIAL FOLDS ON (B)(6) 2015. MEDICAL HISTORY INCLUDED COLD SORES. CONCOMITANT MEDICATION INCLUDED LIDOCAINE. THE PATIENT HAS HAD TWO PREVIOUS RADIESSE INJECTIONS DURING THE PAST THREE YEARS INTO THE NASAL LABIAL FOLDS WITHOUT PROBLEMS. THE PATIENT RECEIVED RADIESSE INJECTIONS TO THE BILATERAL NASAL LABIAL FOLDS (NLF). AFTER MIXING RADIESSE WITH 0.3 CC OF LIDOCAINE, THE PATIENT RECEIVED APPROXIMATELY 1.5 CC OF THE MIXTURE. DURING THE INJECTION OF THE RIGHT NLF, THE PATIENT EXPERIENCED BLANCHING IN THE FOLD AND CHEEK REGION. THE INJECTION WAS DISCONTINUED AND THE AREA MASSAGED. THE COLORATION RETURNED WITHIN 10 MINUTES. THIRTY MINUTES POST-INJECTION, THE PATIENT WAS RELEASED AND NO PROBLEMS WERE EVIDENT. DURING THE NIGHT OF (B)(6) 2015, THE PATIENT EXPERIENCED RIGHT NLF NUMBNESS. ADVIL (IBUPROFEN) WAS TAKEN AND COLD COMPRESSES WERE APPLIED. ON THE MORNING OF (B)(6) 2015, THE NUMBNESS HAD IMPROVED; HOWEVER, THE PATIENT WAS EXPERIENCING SWELLING ON THE RIGHT SIDE. NO BRUISING WAS PRESENT. FOLLOW-UP FROM THE PHYSICIAN REVEALED THE FOLLOWING: UPON EXAMINATION ON (B)(6) 2015, THE PATIENT HAD NO VASCULAR COMPROMISE TO THE ORAL MUCOSA. THERE WAS SLIGHT ERYTHEMA OVER THE RIGHT NLF, CHEEK, AND NOSE. A SMALL AMOUNT OF BRUISING WAS PRESENT OVER THE RIGHT ORAL COMMISSURE REGION. THE PATIENT COMPLAINED OF TENDERNESS OVER HER RIGHT CHEEK. THE PLAN WAS TO MONITOR THE PATIENT DAILY. ON (B)(6) 2015, THE PATIENT'S SKIN WAS INTACT WITH NO CHANGES FROM THE PREVIOUS DAY. THE PATIENT COMPLAINED OF THE "INSIDE OF HER RIGHT CHEEK IS RAW". TREATMENT INCLUDED NITROPASTE TWICE DAILY, WARM COMPRESSES, MASSAGE, A MEDROL (METHYLPREDNISOLONE) DOSE PACK, HEAD ELEVATION, CLARITIN (LORATADINE), AND ZANTAC (RANITIDINE). ON (B)(6) 2015, THE PATIENT WAS DOING "QUITE WELL". SHE HAD DEVELOPED 4-5 SMALL PUSTULES OVER THE NLF REGION. ADDITIONAL TREATMENT INCLUDED VALTREX (VALACYCLOVIR) DUE TO THE PATIENT'S HISTORY OF COLD SORES. THE TENDERNESS IN THE PATIENT'S CHEEK WAS DIMINISHED, BUT SLIGHT DUSKINESS TO THE RIGHT ORAL COMMISSURE REMAINED. ON (B)(6) 2015, THERE WAS NO WORSENING OF THE PUSTULES ON THE RIGHT NLF REGION AND THE ORAL MUCOSA WAS HEALING. SLIGHT TENDERNESS REMAINED TO THE RIGHT UPPER LIP. FOLLOW-UP FROM THE PHYSICIAN ON (B)(6) 2015 STATED THAT THE PHYSICIAN FEELS HIS PATIENT IS "OUT OF THE WOODS" AS FAR AS TISSUE BREAKDOWN. THE CURRENT TREATMENT WILL BE CONTINUED FOR ONE MORE WEEK. FOLLOW-UP FROM THE PHYSICIAN ON 21-AUG-2015 REVEALED THE FOLLOWING: THE PATIENT SENT THE PHYSICIAN PICTURES ON (B)(6) 2015 THAT SHOWED IMPROVEMENT. THE PATIENT WAS CONTINUING TREATMENT WITH ASPIRIN (ACETYLSALICYLIC ACID), NITROGLYCERIN OINTMENT, ZANTAC, AND CLARITIN. THE PHYSICIAN WAS OF THE OPINION THAT THE EVENT WAS POSSIBLY RELATED TO THE EVENT GIVEN IT OCCURRED IN THE SAME LOCATION AND MAY HAVE BEEN DUE TO THE TISSUE BEING MORE FIBROTIC IN THAT AREA DUE TO PREVIOUS RADIESSE INJECTIONS. THE PHYSICIAN STATED THAT THE PATIENT DOES NOT HAVE PERMANENT IMPAIRMENT; HOWEVER, THE POTENTIAL EXISTED IF TREATMENT HAD NOT BEEN GIVEN. FOLLOW-UP WAS RECEIVED FROM THE PHYSICIAN ON 31-AUG-2015. THE PATIENT HAS COMPLETED HER TREATMENT AND "LOOKS GREAT". THE PHYSICIAN PLANS NO FURTHER FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598700 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ NORTH AMERICA 8071M0K1 100070372

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention LIDOCAINE 0.3 CC