BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAVITRON JET-FRESH PROPHY POWDER WITH ALUMINIMUM TRIHYDROXIDE - SODIUM FREE

    MDR report key: 5253731 · Received November 29, 2015

    Report

    Report Number
    2424472-2015-00107
    Event Type
    Malfunction
    Date Received
    November 29, 2015
    Report Date
    October 28, 2015
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    KOJ
    PMA / PMN Number
    K014188
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    PROPHY POWDER IS USED IN CONJUNCTION WITH AN AIR POLISHING PROPHYLAXIS SYSTEM AND AIR POLISHING INSERT TIP TO POLISH THE TOOTH ENAMEL. THE CLINICIAN CONTROLS THE DIRECTION OF THE SPRAY AND THE PRODUCT IS NOT INTENDED TO BE SPRAYED OF TISSUE SURFACE. THE ROOT CAUSE HAS BEEN IDENTIFIED AS IMPROPER USE.

    Additional Manufacturer Narrative · 1

    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 POSSIBLY 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 HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE A CUSTOMER WAS USING JET-FRESH POWDER, THE POWDER WAS SPRAYED INSIDE THE GINGIVAL TISSUE OF A PATIENT AND SWELLING FOLLOWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783655 CAVITRON JET-FRESH PROPHY POWDER WITH ALUMINIMUM TRIHYDROXIDE - SODIUM FREE AIRBRUSH KOJ DENTSPLY PROFESSIONAL NA 1502021

    Patients

    Seq Age Sex Outcome Treatment
    1