BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVIELLE VOICE GEL PLUS

    MDR report key: 1652501 · Received April 5, 2010

    Report

    Report Number
    3003644133-2010-00002
    Event Type
    Injury
    Date Received
    April 5, 2010
    Date of Event
    March 19, 2009
    Report Date
    February 22, 2010
    Manufacturer
    COAPT SYSTEMS, INC.
    Product Code
    MIX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 PLUS IS DESIGNED FOR VOCAL FOLD AUGMENTATION. IF ADD'L INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE PHYSICIAN INJECTED TWO SYRINGES OF NOVIELLE GEL PLUS AROUND THE NASOLABIAL FOLDS AND MARIONETTE LINES ON (B) (6) 2009. THE PT DEVELOPED PAINFUL LUMPS IN THE AREA OF INJECTION. THE PHYSICIAN PRESCRIBED MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVIELLE VOICE GEL PLUS EAR, NOSE & THROAT SYNTHETIC POLYMER MIX COAPT SYSTEMS, INC. 25301 02402

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention