BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVIELLE GEL

    MDR report key: 1736728 · Received June 18, 2010

    Report

    Report Number
    3003644133-2010-00010
    Event Type
    Injury
    Date Received
    June 18, 2010
    Date of Event
    March 22, 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 IN THE CHEEK WITH NOVIELLE GEL (B)(6) 2009. THE PT DEVELOPED LUMPINESS AND REDNESS APPROX 4-5 MONTHS AFTER THE INJECTION. THE PT HAS BEEN TREATED WITH IPL SESSIONS AND SCULTPRA INJECTIONS SINCE (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