BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROFILE CT ROTARY INSTRUMENT

    MDR report key: 606205 · Received May 19, 2005

    Report

    Report Number
    2320721-2005-00165
    Event Type
    Malfunction
    Date Received
    May 19, 2005
    Date of Event
    April 19, 2005
    Report Date
    April 19, 2005
    Manufacturer
    DENTSPLY TULSA
    Product Code
    EKS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    A FILE SEPARATED IN HTE CANAL DURING A PROCEDURE. THE PT IS SCHEDULED FOR FOLLOW-UP TREATMENT. THOUGH OUTCOME OF THE EVENT IS NOT KNOWN AS OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFILE CT ROTARY INSTRUMENT DENTAL FILE EKS DENTSPLY TULSA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR