BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2577634 · Received May 7, 2012

    Report

    Report Number
    2135225-2012-00049
    Event Type
    Other
    Date Received
    May 7, 2012
    Date of Event
    April 5, 2012
    Report Date
    April 12, 2012
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RADIESSE DERMAL FILLER HAD BEEN MIXED WITH 0.3ML XYLOCAINE. THIS PT HAS HAD PRIOR RADIESSE INJECTION WITHOUT ISSUE. THE PT'S SYMPTOM RESOLUTION WAS REPORTED AS "ON-GOING." THE RADIESSE DEVICE HISTORY RECORDS FOR 1027949 WERE REVIEWED. ALL REQUIRED TESTING SPECIFICATIONS FOR THE LOT WERE MET PRIOR TO RELEASE AND THERE WERE NO ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    THIS EVENT WAS REPORTED TO MERZ (B)(4) ON (B)(4) 2012: THE PT WAS INJECTED WITH RADIESSE DERMAL FILLER MIXED WITH 0.3ML XYLOCAINE, ON (B)(6) 2012 TO THE NL FOLDS. ONE HOUR FOLLOWING THE INJECTION, THE PT NOTICED REDNESS ND EDEMA OF THE RIGHT NL FOLD. HEMATOMA AND INDURATION DEVELOPED ON (B)(6). ON (B)(6), THERE WAS THE APPEARANCE OF A WOUND AND CRUSTS ON BOTH ALAR AND NL FOLDS. SWEATING AND BLEEDING OF THE AREA DEVELOPED ON (B)(6). THE PT WAS TREATED WITH SOLUPRED 60MG DAILY FOR 3 DAYS, AUGMENTIN 2G DAILY FOR 10 DAYS, AND ZELITREX 500- 6 TAB DAILY FOR 15 DAYS. THE PT HAD NO HISTORY OF HERPES OUTBREAK. ADDITIONALLY, THE PT WAS TREATED WITH CICATRISING CREAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER RADIESSE INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC. 1027949

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention