BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 1952161 · Received December 29, 2010

    Report

    Report Number
    2135225-2010-00096
    Event Type
    Other
    Date Received
    December 29, 2010
    Date of Event
    November 19, 2010
    Report Date
    December 1, 2010
    Manufacturer
    MERZ AESTHETICS, INC. (FORMERLY BIOFORM MEDICAL, INC.)
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT USED: CATALOG #: 8069M0K1, LOT #: 1021467; EXP DATE: 05/01/2012. DEVICE MANUFACTURE DATE: 05/2010. THE DEVICE HISTORY RECORDS FOR RADIESSE LOTS 1021616 AND 1021467 WERE REVIEWED; ALL REQUIRED TESTING SPECS WERE MET PRIOR TO RELEASE AND THERE WERE NO ABNORMALITIES NOTED FOR THESE LOTS.

    Description of Event or Problem · 1

    A PHYSICIAN ASSISTANT (PA) REPORTED THAT A PT WAS INJECTED WITH RADIESSE ON (B)(6) 2010 INTO PRE JOWL, MARIONETTE LINES AND NASOLABIAL FOLDS, AND EXPERIENCED SWELLING, REDNESS AND STINGING THREE DAYS POST INJECTION. THE PT WENT TO THE ER, WAS PRESCRIBED ORAL PREDNISONE AND RELEASED; DOSE AND FREQUENCY WERE NOT REPORTED. THE PT HAS NO KNOWN ALLERGIES. THE EVENTS WERE NOT DIAGNOSED AS AN ALLERGIC REACTION. ON (B)(6) 2010, THE PT WAS SEEN BY THE INJECTING PA, WHO NOTED "PROFOUND ROSACEA" ON PT'S LOWER CHIN. AS OF (B)(6) 2010, THE PT REPORTED TO HAVE CONTINUED REDNESS, SWELLING, AND STINGING; AND SOME BURNING "IN HER CHEST THAT WAKES HER UP AT NIGHT." THE INJECTING PA DOES NOT WANT TO BE CONTACTED BY (B)(6) COMPLIANCE, CONSULTATION WAS REFUSED. ON (B)(6) 2010, AN UPDATE WAS RECEIVED FROM (B)(6) FIELD CLINICAL SPECIALIST WHO IS IN CONTACT WITH THE INJECTOR; THE PT WAS SEEN BY THE INJECTING PA OVER A WEEK AGO; "STILL REPORTING SOME SYMPTOMS OF IRRITATION, THOUGH NO OBJECTIVE FINDINGS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER RADIESSE INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC. (FORMERLY BIOFORM MEDICAL, INC.) 1021616

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other