BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROULTRA ENDO TIPS

    MDR report key: 1243107 · Received November 21, 2008

    Report

    Report Number
    2320721-2008-00102
    Event Type
    Malfunction
    Date Received
    November 21, 2008
    Date of Event
    October 22, 2008
    Report Date
    October 22, 2008
    Manufacturer
    DENTSPLY TULSA
    Product Code
    ELC
    PMA / PMN Number
    K960889
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH NO INJURY OCCURRED, THERE HAVE BEEN PREVIOUS REPORTS OF THIS MALFUNCTION IN THE PAST TWO YEARS THAT NECESSITATED MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY STRUCTURE OR FUNCTION (THOUGH SUCH INTERVENTION IS INADVISABLE PER EXPERT OPINION PROVIDED BY A DR). THEREFORE, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. THE DEVICE WAS RETURNED, VISUALLY INSPECTED, AND FOUND TO HAVE SEPARATED APPROXIMATELY 21 MM FROM THE BEND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PROULTRA TIP #5 SEPARATED IN A PRACTICE BLOCK. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROULTRA ENDO TIPS ELC DENTSPLY TULSA NA 080608308

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SATELEC P-5 ULTRASONIC BOOSTER