BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROULTRA

    MDR report key: 565630 · Received January 10, 2005

    Report

    Report Number
    2029155-2004-00575
    Event Type
    Malfunction
    Date Received
    January 10, 2005
    Date of Event
    December 7, 2004
    Report Date
    December 7, 2004
    Manufacturer
    DENTISPLY TULSA
    Product Code
    ELC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DOCTOR REPORTED THAT PROULTRA ENDO TIP SEPERATED WHILE ATTEMPTING TO REMOVE A SILVER POINT. THE SEPERATED PIECES WERE SUCCESSFULLY RETRIEVED AND THERE IS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROULTRA ENDO TIP ELC DENTISPLY TULSA NA 209236

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR