BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HENRY SCHEIN PRECISION-TORQUE

    MDR report key: 8650288 · Received May 29, 2019

    Report

    Report Number
    3007007357-2019-00003
    Event Type
    Malfunction
    Date Received
    May 29, 2019
    Date of Event
    April 16, 2019
    Report Date
    May 28, 2019
    Manufacturer
    HANDPIECE HEADQUARTERS INC.
    Product Code
    EFB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WE ARE SUPPLEMENTING OUR INITIAL MFR REPORT #3007007357-2019-00003 WITH A CORRECTION ON CATALOG # UNDER SECTION D. SUSPECT MEDICAL DEVICE. THE ORIGINAL LISTED CATALOG # WAS 101-8786. THE CORRECTED/UPDATED CATALOG # IS: 102-4339. ALL OTHER INFORMATION ARE THE SAME.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE HAS UNDERGONE THREE REPAIRS DATING IN 2017, 2018, AND 2019. THE LATEST REPAIR IN 2019 WAS DONE BY REPLACING THE COMPLETE TURBINE WITH A NEW TURBINE, MANUFACTURED IN JULY OF 2018. UPON VISUAL AND OPERATIONAL INSPECTIONS, THE HANDPIECE AND TURBINE WERE VERIFIED TO BE PERFORMING AS INTENDED, NO ISSUES WERE IDENTIFIED.

    Description of Event or Problem · 1

    WHILE THE DENTIST WAS OPERATING ON A PATIENT, THE BUR CAME OUT OF THE HANDPIECE AND THE PATIENT SWALLOWED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444438 HENRY SCHEIN PRECISION-TORQUE HANDPIECE EFB HANDPIECE HEADQUARTERS INC. PRECISION-TORQUE 383791

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other