BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCITE F DSC

    MDR report key: 3873730 · Received September 24, 2013

    Report

    Report Number
    9612352-2013-00010
    Event Type
    Malfunction
    Date Received
    September 24, 2013
    Date of Event
    September 3, 2014
    Report Date
    September 20, 2013
    Manufacturer
    IVOCLAR VIVADENT AG
    Product Code
    KLE
    PMA / PMN Number
    K093744
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ADDITIONAL QUALITY CONTROL MONITORING USING UV/VIS ANALYSIS HAS ALREADY BEEN IMPLEMENTED. THE FIELD SAFETY CORRECTIVE ACTION IS IN PREPARATION AND WILL BE NOTIFIED TO THE AUTHORITIES IMMEDIATELY.

    Description of Event or Problem · 1

    THE DENTIST FOUND THAT TEN VENEERS WHICH SHE CEMENTED WITH VARIOLINK II AND EXCITE F DSC HAD A GREEN DISCOLORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483207 EXCITE F DSC AGENT, TOOTH BONDING RESIN, PRODUCT CODE KLE KLE IVOCLAR VIVADENT AG 630378AN

    Patients

    Seq Age Sex Outcome Treatment
    1