BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSHING RONGEUR

    MDR report key: 1844953 · Received September 8, 2010

    Report

    Report Number
    1844953
    Event Type
    Malfunction
    Date Received
    September 8, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 8, 2010
    Manufacturer
    CODMAN
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 'TOOTH' OF THE CLOWARD BROKE OFF INSIDE OF THE PATIENT AFTER THE PIECE HAD BIT DOWN ON A PIECE OF TISSUE. THE PHYSICIAN WAS PULLING THE DEVICE OUT OF THE BODY AND NOTED THE TOOTH MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSHING RONGEUR RONGEUR LXH CODMAN * *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR