BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    301 ELEV

    MDR report key: 3871286 · Received April 15, 2014

    Report

    Report Number
    2523190-2014-00020
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Report Date
    March 31, 2014
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    DZA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTS TIP BROKE. ON (B)(6) 2014 REPORTS NO HARM DONE, GAUZE PACKS USED TO PREVENT PT FROM SWALLOWING BROKEN PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230642 301 ELEV M51 - GENERAL DENTISTRY DZA INTEGRA YORK, PA INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1