BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    46 ELEV.

    MDR report key: 3832010 · Received March 7, 2014

    Report

    Report Number
    2523190-2014-00013
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Report Date
    February 27, 2014
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    EMJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    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 BROKEN TIP DURING EXTRACTION. ON 02/28/2014 DEALER REPORTS NO HARM DONE, BROKEN PIECE REMOVED FROM MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138599 46 ELEV. M51 - GENERAL DENTISTRY EMJ INTEGRA YORK, PA INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1