BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N-TRALIG IN INTRLGMNTRY SYRG

    MDR report key: 4692950 · Received April 13, 2015

    Report

    Report Number
    2523190-2015-00014
    Event Type
    Malfunction
    Date Received
    April 13, 2015
    Date of Event
    March 10, 2015
    Report Date
    March 17, 2015
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    EKJ
    PMA / PMN Number
    K823536
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTS BARREL AND TIP BROKE OFF. ON (B)(6) 2015 DOCTOR REPORTS THAT WHEN ATTEMPTING TO MEDICATE FOR A FILLING, THE NEEDLE AND HUB BROKE OFF OF THE SYRINGE IN THE PTS MOUTH. PART WAS RETRIEVED, NO HARM WAS DONE TO THE PT. NO FURTHER INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244612 N-TRALIG IN INTRLGMNTRY SYRG M51 - GENERAL DENTISTRY EKJ INTEGRA YORK, PA INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1