BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUREFIT

    MDR report key: 2223108 · Received August 19, 2011

    Report

    Report Number
    2223108
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 19, 2011
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CONMED SUREFIT DUAL DISPERSIVE ELECTRODE DOES NOT PROVIDE ADEQUATE CONTACT TO THE PATIENT (DOES NOT STICK PROPERLY). THESE PADS ARE USED WITH ELECTROSURGICAL EQUIPMENT. DUE TO FAILURE OF PADS, THERE IS POTENTIAL FOR POSSIBLE HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUREFIT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONMED ELECTROSURGERY * 1106025

    Patients

    Seq Age Sex Outcome Treatment
    1 *