BEUDAMED
    FDA Adverse Event Other Summary report: N

    MULTILINK AUTOMIX

    MDR report key: 1946219 · Received November 16, 2010

    Report

    Report Number
    9612352-2010-00004
    Event Type
    Other
    Date Received
    November 16, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 26, 2010
    Manufacturer
    IVOCLAR VIVADENT, AG
    Product Code
    EMA
    PMA / PMN Number
    K032470
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    SENSITIVITY REPORTED AFTER USE OF DEVICE WHICH RESULTED IN ENDODONTIC TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTILINK AUTOMIX DENTAL CEMENT EMA IVOCLAR VIVADENT, AG N36867

    Patients

    Seq Age Sex Outcome Treatment
    1 PREEXISTING FRACTURED TOOTH WAS REPORTED