BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2507290 · Received February 28, 2012

    Report

    Report Number
    2135225-2012-00024
    Event Type
    Other
    Date Received
    February 28, 2012
    Date of Event
    January 18, 2012
    Report Date
    February 2, 2012
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS FOR RADIESSE LOT 1030151 WERE REVIEWED. ALL REQUIRED TESTING SPECIFICATIONS FOR THE LOT WERE MET PRIOR TO RELEASE AND THERE WERE NO ABNORMALITIES NOTED. ALTHOUGH THE PT'S SYMPTOMS WERE RESOLVING, AN UPDATE HAS NOT BEEN PROVIDED AS OF 02/02/2012.

    Description of Event or Problem · 1

    DR. (B)(6) INJECTED A PT WITH RADIESSE DERMAL FILLER ON (B)(6) 2011. THE PT WAS NEW TO THEIR OFFICE; SHE WAS INJECTED WITH 1.5 CC RADIESSE BELOW THE ORBITAL RIMS. THE PT REPORTED PAIN OF THE LEFT SIDE, WITH STRANDING AROUND THE INJECTION SITES, WHICH IS AGGRAVATED BY PRESSURE. THE PT WENT TO THE ER (LIVES DISTANCE AWAY FROM (B)(6)) FOR TREATMENT ON (B)(6) 2012. THE PT WAS PRESCRIBED AUGMENTIN AND NARCOTIC PAIN MEDS. THE PT RETURNED (B)(6) FOR F/U ON (B)(6) 2012. THE TENDERNESS HAS IMPROVED, THERE IS NO TISSUE WITH LACRIMAL DUCTS, AND ONE NODULE WAS DETECTED ON THE LEFT SIDE. NO SYMPTOMS DEVELOPED ON THE RIGHT SIDE. BLOODWORK WAS CONDUCTED; ALL RESULTS WERE NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER RADIESSE INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC. 1030151

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention