BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENTAL HANDPIECE

    MDR report key: 7100891 · Received December 7, 2017

    Report

    Report Number
    MW5073844
    Event Type
    Injury
    Date Received
    December 7, 2017
    Date of Event
    November 29, 2017
    Report Date
    December 6, 2017
    Manufacturer
    STAR DENTAL
    Product Code
    EFB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE BURR CAME OUT OF HANDPIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877995 DENTAL HANDPIECE DENTAL HANDPIECE AND ACCESSORIES EFB STAR DENTAL 430 SW

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention