BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRACEY 9/10 CUR #6 HNDLE

    MDR report key: 2999109 · Received February 22, 2013

    Report

    Report Number
    2523190-2013-00010
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Report Date
    February 22, 2013
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    DZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 ON THE REPORTED INFO.

    Description of Event or Problem · 1

    TIP BROKE OFF, PT ALMOST SWALLOWED DUE TO GAG REFLEX (B)(6) 2013. DOCTOR WAS SCALING AND PLANING TEETH WHEN THIS OCCURRED, NO HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78432 GRACEY 9/10 CUR #6 HNDLE M52 - HYGIENE / PERIODONTAL DZP INTEGRA YORK, PA INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1