BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRASSELER USA CARBIDE BUR

    MDR report key: 7071875 · Received November 30, 2017

    Report

    Report Number
    1032227-2017-00006
    Event Type
    Malfunction
    Date Received
    November 30, 2017
    Date of Event
    October 31, 2017
    Report Date
    November 30, 2017
    Manufacturer
    BRASSELER U.S.A. DENTAL, LLC
    Product Code
    EJL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. BURS FROM INVENTORY WERE CHECKED. ALL BURS CHECKED WERE FOUND TO MEET SPECIFICATIONS. UNABLE TO DETERMINE CAUSE OF BUR WALK OUT, BUT MAY BE DUE TO A WORN HANDPIECE COLLET. THIS IS AN ISOLATED OCCURRENCE.

    Description of Event or Problem · 1

    DOCTOR NOTED BUR WOULD NOT STAY IN HANDPIECE AND A PATIENT HAD ONE GO DOWN THEIR THROAT. PATIENT WAS NOT SENT FOR X-RAYS INITIALLY BECAUSE WAS BREATHING FINE AND NO ISSUES AFTER INCIDENT. BUR WAS FOUND IN STOOL LATER THE NEXT DAY. FOLLOW UP VISIT TO DENTAL OFFICE ON (B)(6) 2017 NOTED PATIENT WAS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852433 BRASSELER USA CARBIDE BUR DENTAL CARBIDE BUR EJL BRASSELER U.S.A. DENTAL, LLC H7.33.008

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR