BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVIELLE VOICE

    MDR report key: 1692350 · Received May 14, 2010

    Report

    Report Number
    3003644133-2010-00005
    Event Type
    Injury
    Date Received
    May 14, 2010
    Date of Event
    March 19, 2009
    Report Date
    April 28, 2010
    Manufacturer
    COAPT SYSTEMS, INC.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 WAS DESIGNED AND MARKETED 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 VIA MEDWATCH REPORT (B) (4) THAT THE PT WAS INJECTED AT MULTIPLE FACIAL SITES WITH NOVIELLE. THE PT DEVELOPED DARK CIRCLES AROUND EYES 45 DAYS POST-INJECTION. LUMPS AND OPEN WOUNDS HAVE ALSO DEVELOPED AT THE INJECTION SITES. THE PHYSICIAN TREATED THE INJECTION AREAS WITH PREDNISONE AND ANTIBIOTICS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention