BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HENRY SCHEIN

    MDR report key: 7336005 · Received March 13, 2018

    Report

    Report Number
    2411236-2018-00005
    Event Type
    Injury
    Date Received
    March 13, 2018
    Date of Event
    February 16, 2018
    Report Date
    February 16, 2018
    Manufacturer
    SHENZHEN SUPERLINE TECHNOLOGY CO., LTD
    Product Code
    EKW
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DURING A ROOT CANAL PROCEDURE, A (B)(6) YEAR OLD FEMALE PATIENT HAD THE HEDSTROM FILE BREAK IN THE CANAL. THE PATIENT WAS REFERRED TO SEE A SPECIALIST THE NEXT DAY TO HAVE THE FILE REMOVED. IT IS UNKNOWN IF THE BROKEN FILE WAS ABLE TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177891 HENRY SCHEIN HEDSTROM FILES EKW SHENZHEN SUPERLINE TECHNOLOGY CO., LTD 17110103

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other