BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSEQUENCE

    MDR report key: 6818963 · Received August 24, 2017

    Report

    Report Number
    1032227-2017-00004
    Event Type
    Malfunction
    Date Received
    August 24, 2017
    Date of Event
    July 24, 2017
    Report Date
    August 24, 2017
    Manufacturer
    FKG DENTAIRE SA
    Product Code
    EKS
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    SIZE 40 AND 25 FILES BROKE OFF IN PATIENT'S MOUTH. FILE IS STILL LODGED IN THE PATIENT'S CANAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599369 ENDOSEQUENCE ENDODONTIC FILE EKS FKG DENTAIRE SA SEQ MED RF 04 25 ASST 34678

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR