BEUDAMED
    FDA Adverse Event Summary report: N

    IPS CERAMIC ETCHING GEL

    MDR report key: 4381585 · Received December 31, 2014

    Report

    Report Number
    9612352-2014-00004
    Date Received
    December 31, 2014
    Date of Event
    October 10, 2014
    Report Date
    December 30, 2014
    Manufacturer
    IVOCLAR VIVADENT AG
    Product Code
    ELL
    PMA / PMN Number
    K923926
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE MATERIAL BUST OUT OF THE BOTTLE WHEN IT WAS OPENED SPLASHING INTO THE EYE OF THE DENTAL ASSISTANT AND ONTO THE FURNITURE. THE ASSISTANT WENT TO THE ER AND WAS RELEASED. IT WAS REPORTED THAT THERE WAS NO PERMANENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863147 IPS CERAMIC ETCHING GEL CERAMIC ETCHING GEL ELL IVOCLAR VIVADENT AG T19195

    Patients

    Seq Age Sex Outcome Treatment
    1 Other