BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVIELLE GEL PLUS

    MDR report key: 1736727 · Received June 18, 2010

    Report

    Report Number
    3003644133-2010-00009
    Event Type
    Injury
    Date Received
    June 18, 2010
    Date of Event
    March 24, 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 THE PT WAS INJECTED WITH 1.3CCS OF NOVIELLE GEL PLUS IN THE MARIONETTE LINES AND CHEEKS (B)(6) 2009. THE PT DEVELOPED REDNESS AND LUMPS IN THE AREA OF INJECTIONS. A BLOOD SANGUINEOUS FLUID WAS EXTRACTED FROM THE MARIONETTE LINES (B)(6) 2010. KEFLEX WAS PRESCRIBED AND AN IPL TREATMENT WAS PERFORMED (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVIELLE GEL PLUS EAR, NOSE & THROAT SYNTHETIC POLYMER LMH COAPT SYSTEMS, INC. 26501 02633

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention