BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRACEY 9/10 CUR #6 HNDLE

    MDR report key: 2576109 · Received May 10, 2012

    Report

    Report Number
    2523190-2012-00047
    Event Type
    Malfunction
    Date Received
    May 10, 2012
    Report Date
    May 10, 2012
    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 EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THE TIP OF THE INSTRUMENT BROKE IN THE PT'S MOUTH, AFTER SHARPENING, AND IS CONCERNED IT COULD HAVE BEEN SWALLOWED THOUGH IT WAS NOT. NO PT HARM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1