BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2860302 · Received November 15, 2012

    Report

    Report Number
    2135225-2012-00093
    Event Type
    Other
    Date Received
    November 15, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 23, 2012
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTIVE TREATMENT ON (B)(6) 2012 INCLUDED CEPHALEXIN 500MG, EACH SIX HOURS AND PREDSIN 120MG (PREDNISOLONE) EACH 12 HOURS, THEY WERE PRESCRIBED TO BE USED FOR SEVEN DAYS. THE SWELLING RETURNED 48 HOURS LATER AT THE END OF THE TREATMENT AND THE MEDICINES WERE REINTRODUCED. THE EVENTS RESOLVED 48 HOURS AFTER THE SECOND CORRECTIVE TREATMENT. THE OUTCOME OF THE EVENTS WAS REPORTED AS RESOLVED. F/U CONTACT RECEIVED ON 10/24/2012: THE PHYSICIAN REPORTED THAT THE MEDICINE TO TREAT PULMONARY FIBROSIS HAS BEEN AZITHROMYCIN 500MG TWICE A DAY. ABOUT THE TREATMENT TO THE EVENTS, SHE INFORMED THE MEDICINES WERE TAKEN JUST FOR FIVE DAYS, AGAINST HER RECOMMENDATION, AND THEN THE EVENTS REAPPEARED 47 HOURS LATER, THE INTERRUPTION. THE CORTICOID HAS BEEN TAKEN UNTIL THE MOMENT OF CONTACT. THE RECOVERING HAS BEEN EVALUATED BY THE REPORTER. F/U CONTACT RECEIVED ON 10/30/2012: PHYSICIAN INFORMED THE PT GOT BETTER, THE CORTICOID DOSAGE WAS REDUCED AND THERE WAS NO MORE COMPLAINTS. F/U CONTACT RECEIVED ON 11/08/2012: PHYSICIAN INFORMED THE PT WAS TOTALLY RECOVERED AT THAT TIME. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATED THE REPORTED LOT #1027209 MET ALL SPECS PRIOR TO RELEASE WITH NO ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PT EXPERIENCED HEMATOMA DURING THE RADIESSE PROCEDURE. ON (B)(6) 2012, THE PT REPORTED TO THE PHYSICIAN AN INTENSE INFLAMMATORY PROCESS CHARACTERIZED BY SWELLING, HYPERAEMIA, BURNING AND PAIN THAT REACHED THE FOREARM AND FINGERS. RADIESSE WAS DILUTED IN LIDOCAINE 2% WITHOUT VASOCONSTRICTOR, AND APPLIED VIA DERMAL, CHLORHEXIDINE WAS USED AS ASEPTIC. AFTER THE PROCEDURE THE PT MADE PHYSICAL EXERCISES. IN THE OPINION OF THE REPORTER, THE EVENT OF INFLAMMATORY PROCESS WAS OF SEVERE INTENSITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC. 1027209

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention