BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30K FOCUSED SPRAY SLIMLINE FITGRIP INSERT

    MDR report key: 4798697 · Received May 21, 2015

    Report

    Report Number
    2424472-2015-00027
    Event Type
    Malfunction
    Date Received
    May 21, 2015
    Report Date
    April 23, 2015
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    ELC
    PMA / PMN Number
    K033705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLE CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE INSERT WAS EVALUATED AND MET SPECIFICATION. THE HOTTEST OBSERVED TEMPERATURE WAS 89.9F. THIS IS WITHIN THE LIMITS FOR SAFE USAGE. A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A CAVITRON FITGRIP 30K FSI-SLI-1000 INSERT TIP WAS "GETTING TOO HOT"; NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333537 30K FOCUSED SPRAY SLIMLINE FITGRIP INSERT ULTRASONIC SCALER ELC DENTSPLY PROFESSIONAL 4310

    Patients

    Seq Age Sex Outcome Treatment
    1