BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS

    MDR report key: 3022731 · Received March 22, 2013

    Report

    Report Number
    3022731
    Event Type
    Malfunction
    Date Received
    March 22, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 22, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    EQJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TURBINATE BLADE BROKE WHILE IN USE ON PATIENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?SINUS ENDOSCOPY AND RESECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119114 XPS BUR, EAR NOSE AND THROAT EQJ MEDTRONIC XOMED, INC. 2MM 59796500

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR