BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCHEIN HEDSTRM 25MM SZ 10

    MDR report key: 2211060 · Received August 5, 2011

    Report

    Report Number
    2523190-2011-00057
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Report Date
    August 5, 2011
    Manufacturer
    INTEGRA, YORK - IMILTEX
    Product Code
    EKS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE FILE TIPS ARE BREAKING UPON INSERTING INTO THE CANAL AS WELL AS WHEN PUTTING THE RUBBER STOP ON THE FILE. THIS IS A NEW FILE RIGHT FROM THE BOX. THE FILES BREAK IN THE TOOTH CANAL AND THE PT WAS SENT TO AN ENDODONTIC. THE ITEM WILL NOT BE RETURNED. IT WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCHEIN HEDSTRM 25MM SZ 10 M50 - ENDODONTICS EKS INTEGRA, YORK - IMILTEX

    Patients

    Seq Age Sex Outcome Treatment
    1