BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2679638 · Received July 30, 2012

    Report

    Report Number
    2135225-2012-00079
    Event Type
    Injury
    Date Received
    July 30, 2012
    Date of Event
    July 11, 2012
    Report Date
    July 16, 2012
    Manufacturer
    MERZ AESTHETICS
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT RETURNED FOR EVALUATION ON (B)(6) 2012 AND WAS MUCH IMPROVED AFTER TAKING KEFLEX AND PREDNISONE. BOTH THE RN AND MEDICAL DIRECTOR BELIEVE AN INFECTION MAY HAVE BEEN PRESENT. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THE REPORTED LOT #1033825 MET ALL SPECIFICATIONS PRIOR TO RELEASE WITH NO ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    RN REPORTED INJECTING A PATIENT WITH RADIESSE DERMAL FILLER IN THE NASOLABIAL FOLDS, CHEEKS AND ORAL COMMISSURES ON (B)(6) 2012. ONE DAY LATER, THE PATIENT REPORTED SWELLING. THE FOLLOWING DAY SHE RETURNED TO THE SPA COMPLAINING OF AN AREA ON ONE SIDE OF HER FACE WHICH WAS VERY WARM, VERY TENDER WITH PAINFUL BURNING INSIDE OF HER MOUTH. ALSO PRESENT WAS A REDDISH STREAK WITH PEELING OF THE SKIN BETWEEN THE ORAL COMMISSURE AND NASOLABIAL FOLD. THE PATIENT WAS PRESCRIBED PREDNISONE AND KEFLEX, 500 MG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ AESTHETICS 1033825

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention