BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2176658 · Received July 13, 2011

    Report

    Report Number
    2135225-2011-00069
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    June 23, 2011
    Report Date
    July 8, 2011
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) DESCRIBED THE ONSET OF PAIN, SWELLING AND REDNESS TO THE LEFT NARE AND SUPERIOR NLF THAT STARTED WITHIN 24 HOURS OF HER NLF TREATMENT. (B)(6) INSTRUCTED THE PT TO USE 1000 MG OF VIT C AND K AS WELL AS TRIAMCINOLONE CREAM TO THE AFFECTED AREAS. THE PT IS A SMOKER AS WELL. THE SWELLING IMPROVING BUT THE CRUSTS REMAIN ON THE NLF AND NARE. PT IS ALREADY USING AQUAPHOR AS PART OF HER DAILY REGIMEN. SMOKING CESSATION IS STRONGLY ENCOURAGED IN ORDER TO EXPEDITE AND OPTIMIZE THE HEALING PROCESS. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THE REPORTED LOTS #1025772 AND 1022653 MET ALL SPECIFICATIONS PRIOR TO RELEASE. ADDITIONAL MODEL#: 8042M0K3, LOT#: 1022653, EXPIRATION DATE: 07/2012, DEVICE MANUFACTURE DATE: 07/2010.

    Description of Event or Problem · 1

    (B)(6) INJECTED PT ON (B)(6) 2011 IN THE NASOLABIAL FOLDS. THE PT DEVELOPED SEVERE SWELLING IMMEDIATELY FOLLOWING INJECTION. ON (B)(6) 2011, THE PT PRESENTED WITH PURPLISH/RED DISCOLORATION, WHITEHEADS AND BLACK SCABBING FLAKY AREA OF SKIN AT THE NARE OF THE LEFT NASOLABIAL FOLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER RADIESSE INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC. 8071M0K1 1025772

    Patients

    Seq Age Sex Outcome Treatment
    1 Other