BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3T

    MDR report key: 5821721 · Received July 26, 2016

    Report

    Report Number
    5821721
    Event Type
    Malfunction
    Date Received
    July 26, 2016
    Date of Event
    July 1, 2016
    Report Date
    July 20, 2016
    Manufacturer
    PREMIER DENTAL PRODUCTS CO.
    Product Code
    EMH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DURING A DENTAL PROCEDURE AN INSTRUMENT BROKE IN THE PATIENT'S MOUTH DURING USE. THE PATIENT HAD A THROAT PACK IN DURING PROCEDURE. SURGEON WAS ABLE TO RETRIEVE THE MISSING PIECE AND BOTH PIECES OF THE INSTRUMENT WERE REMOVED FROM THE FIELD AND SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475336 3T FORCEPS, RONGEUR, SURGICAL EMH PREMIER DENTAL PRODUCTS CO. 3T

    Patients

    Seq Age Sex Outcome Treatment
    1