BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVIELLE GEL

    MDR report key: 1736742 · Received June 18, 2010

    Report

    Report Number
    3003644133-2010-00008
    Event Type
    Injury
    Date Received
    June 18, 2010
    Date of Event
    April 29, 2010
    Report Date
    June 9, 2010
    Manufacturer
    COAPT SYSTEMS, INC.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR, THEREFORE, AN INVESTIGATION TO DETERMINE ROOT CAUSE COULD NOT BE CONDUCTED. NOVIELLE GEL IS DESIGNED FOR VOCAL FOLD AUGMENTATION. IF ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT ON (B)(6) 2009, THE PT WAS INJECTED IN THE MARIONETTE LINES AND PRE-JOWL WITH 0.5CCS OF NOVIELLE GEL. THE PT DEVELOPED REDNESS AND LUMPINESS. ON (B)(6) 2010, THE PT BEGAN BIAXON 500MG TWICE A DAY FOR SEVEN DAYS. KENALOG 10 0.5CC WAS INJECTED DIRECTLY INTO THE PRE-JOWL AND MARIONETTE LINES. FIVE SESSIONS OF IPL BETWEEN (B)(6) 2009, AND (B)(6) 2010, HAVE BEEN PROVIDED. FRAXEL TREATMENT WAS PERFORMED (B)(6) 2010, WITH ANOTHER TREATMENT SCHEDULED FOR (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVIELLE GEL EAR, NOSE & THROAT SYNTHETIC POLYMER LMH COAPT SYSTEMS, INC. 24601 02634

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention