BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2634179 · Received June 20, 2012

    Report

    Report Number
    2135225-2012-00070
    Event Type
    Other
    Date Received
    June 20, 2012
    Date of Event
    April 21, 2012
    Report Date
    May 22, 2012
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AT THE TIME OF THE REPORT THE PATIENT WAS RESOLVED.

    Description of Event or Problem · 1

    THE PATIENT WAS INJECTED WITH THREE 1.5CC SYRINGES OF RADIESSE (LOT 1030146) ON (B)(6) 2012 IN THE CHEEKS AND NLFS. THE PATIENT IS A FIREFIGHTER WHO IS IN AND OUT OF SMOKE AND WEARS A MASK A LOT. THE PATIENT IS ALSO A BODY BUILDER WHO (B)(6) DESCRIBES AS NON-COMPLAINT. SHE WORKS OUT AND OVER HEATS. ON (B)(6) 2012, THE PATIENT CAME IN AND HAD ONE LITTLE SPOT ON THE RIGHT SIDED FOLD THAT HAD REDNESS. SHE WAS TOLD TO WATCH IT FOR A COUPLE OF DAYS. SHE CALLED AND CAME BACK ON (B)(6) 2012 (PHOTOS WERE TAKEN). DR. (B)(6) SAW THE PATIENT AND PRESCRIBED KEFLEX 250MG FOR 10 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER RADIESSE INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC. 1030146

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention