BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    301 ELEV.

    MDR report key: 3908752 · Received May 12, 2014

    Report

    Report Number
    2523190-2014-00021
    Event Type
    Malfunction
    Date Received
    May 12, 2014
    Report Date
    April 15, 2014
    Manufacturer
    INTEGRA YORK PA INC
    Product Code
    DZA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    DEALER INITIALLY REPORTS TIP IS BROKEN. ON (B)(6) 2014 HYGIENIST REPORTS NO HARM DONE. DOCTOR WAS ELEVATING A TOOTH AND USED PREVENTATIVE MEASURES (GAUZE PACKS) TO SAVE PATIENT FROM SWALLOWING PARTS. NO FURTHER INFORMATION AVAILABLE, EVENT TOOK PLACE SOMETIME IN (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284923 301 ELEV. M51 - GENERAL DENTISTRY DZA INTEGRA YORK PA INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1