BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2143122 · Received June 17, 2011

    Report

    Report Number
    2135225-2011-00060
    Event Type
    Other
    Date Received
    June 17, 2011
    Date of Event
    May 7, 2011
    Report Date
    May 19, 2011
    Manufacturer
    MERZ AESTHETIC, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER DISCUSSION WITH THE PHYSICIAN'S OFFICE ON (B)(6) 2011, THE PT IS FINE. THE DEVICE HISTORY RECORDS WERE REVIEWED, ALL REQUIRED TESTING SPECIFICATIONS WERE MET PRIOR TO RELEASE, THERE WERE NO ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT WAS INJECTED WITH THREE 1.5CC RADIESSE SYRINGES IN THE CHEEKS AND NLFS. ON (B)(6) 2011, THE PATIENT WAS RED, SWOLLEN AND INFLAMED FROM THE CHEEK TO THE EYE. THE TREATMENT WAS PEDIBORO (POWDER MIXED IN A LITER OF WATER USED FOR COLD COMPRESSES) A FEW TIMES A DAY FOR ONE WEEK. THE PT WAS PRESCRIBED CIPRO 500MG TWO TIMES PER DAY FOR ONE WEEK. THE PT WAS ALSO PRESCRIBED A MEDROL DOSE PACK. PER DISCUSSION WITH THE INJECTING PHYSICIAN, THE RIGHT CHEEK WAS FINE. THE LEFT CHEEK BLEW UP. THE PT WAS PRESCRIBED A Z PACK AND WENT TO THE EMERGENCY ROOM. THE PROBLEM EXTENDED TO THE EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER RADIESSE INJECTABLE IMPLANT LMH MERZ AESTHETIC, INC. 1023308

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R EACH RADIESSE SYRINGE WAS MIXED WITH 0.5CC OF| LIDOCAINE.