BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NANO TIP

    MDR report key: 7139674 · Received December 21, 2017

    Report

    Report Number
    1718912-2017-00042
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Date of Event
    September 29, 2016
    Report Date
    December 21, 2017
    Manufacturer
    ULTRADENT PRODUCTS INC
    Product Code
    EIC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INVOLVEMENT, ONE TIP WAS REPORTED TO HAVE A LOOSE CANULA AND IT WAS CONFIRMED UPON PRODUCT RETURN. NO MDR WAS FILED SINCE THE CANULA WAS HELD IN PLACE AND NO INJURY HAD OCCURED NOR WAS THERE A POSSIBILITY OF PATIENT INJURY. HOWEVER, A SECOND COMPLAINT WAS RECEIVED FOR THE SAME LOT WHERE THE CANULA HAD COME OUT OT THE HUB, IT WAS FELT OUT OF AN ABUNDANCE OF CAUTION BOTH THIS AND A SECOND MDR WOULD BE FILED. THEREFORE THIS FILING IS LATE DUE TO FACT NEW INFORMATION OF CANULAS COMING OUT HAS NOW BEEN CONFIRMED. NO INJURY, BUT TIP DID MALFUNCTION WHICH, THOUGH UNLIKELY THE CANULA COULD COME OUT AND POSE A THREAT IF SWALLOWED. REFILE DUE TO MAUDE DATA BASE LOADING ISSUE.

    Description of Event or Problem · 1

    DENTAL OFFICE STATES THE CANNULA OF A NANOTIP BROKE LOOSE AND WAS SPINNING IN THE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916801 NANO TIP NANO TIP EIC ULTRADENT PRODUCTS INC BCTBY

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other