BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROULTRA

    MDR report key: 635529 · Received September 15, 2005

    Report

    Report Number
    2029155-2005-00381
    Event Type
    Malfunction
    Date Received
    September 15, 2005
    Date of Event
    August 17, 2005
    Report Date
    August 17, 2005
    Manufacturer
    DENTSPLY TULSA DENTSPLY TULSA
    Product Code
    ELC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PROULTRA ENDO TIP SEPERATED INTO TWO PIECES IN A PT'S TOOTH. THE SEPERATED PIECES WERE RETRIEVED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROULTRA ENDO TIPS ELC DENTSPLY TULSA DENTSPLY TULSA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN