BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2439213 · Received January 26, 2012

    Report

    Report Number
    2135225-2012-00011
    Event Type
    Other
    Date Received
    January 26, 2012
    Date of Event
    October 15, 2011
    Report Date
    January 16, 2012
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS FOR RADIESSE LOT 1024265 WERE REVIEWED. ALL REQUIRED TESTING SPECS FOR LOT 1022316 WERE MET PRIOR TO RELEASE, THERE WERE NO ABNORMALITIES NOTED. AT THE TIME THIS EVENT WAS REPORTED. THE PT'S SYMPTOMS RESOLVED, AND THERE WAS NO RECURRENCE AT THE PT'S APPOINTMENT WITH DR (B)(6) 2-MONTHS FOLLOWING THE EVENT.

    Description of Event or Problem · 1

    (B)(6) - OFFICE ASST FOR DR (B)(6), INDICATED THAT A PT INJECTED WITH RADIESSE DERMAL FILLER ON (B)(6) 2011, HAD DEVELOPED AN INFECTION. THE PT WAS INJECTED WITH RADIESSE IN THE CHEEK HOLLOWS. OVER THE WEEKEND ((B)(6)), THE PT DEVELOPED TENDERNESS AND PUS DRAINAGE OF THE LEFT CHEEK. THE PT LIVES QUITE A DISTANCE FROM DR (B)(6) OFFICE; THE PT EMAILED PHOTOS AND DR (B)(6) PRESCRIBED AMOXICILLIN 250MG OVER THE PHONE. THE PT'S SYMPTOMS RESOLVED AFTER TAKING THE ANTIBIOTICS AND APPLYING WARM, MOIST HEAT TO THE AREA. AT A 2 MONTH F/U APPOINTMENT WITH DR (B)(6) FOR A TOOTH CLEANING, DR (B)(6) DID NOT NOTE ANY RESIDUAL INFECTION OR REDNESS, AND THERE WAS NO SCARRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER RADIESSE INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC. 1024265

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention