BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROULTRA

    MDR report key: 677335 · Received February 15, 2006

    Report

    Report Number
    2029155-2006-00020
    Event Type
    Malfunction
    Date Received
    February 15, 2006
    Date of Event
    January 16, 2006
    Report Date
    January 16, 2006
    Manufacturer
    DENTSPLY TULSA
    Product Code
    ELC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PROULTRA ENDO TIP SEPERATED IN A PT'S TOOTH, DURING A PROCEDURE. THE SEPERATED PIECE WAS RETIREVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN