BEUDAMED
    FDA Adverse Event Other Summary report: N

    DURA-STICK II SELF-ADHESIVE ELECTRODES

    MDR report key: 2275494 · Received October 3, 2011

    Report

    Report Number
    1022819-2011-00011
    Event Type
    Other
    Date Received
    October 3, 2011
    Date of Event
    August 1, 2011
    Report Date
    September 30, 2011
    Manufacturer
    DJO LLC
    Product Code
    IPF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L DATA: ACTUAL ELECTRODES USED DURING THE EVENT WERE NOT RETURNED FOR EVAL. UNUSED ELECTRODES FROM SAME PACKAGE WERE RETURNED AND EVALUATED WITH NO ISSUES FOUND. CORRECTED DATA: REPORT ORIGINALLY ISSUED AND SUBMITTED WITH INCOMPLETE MFR REPORT NUMBER 1022819-2011-00009. MFR REPORT NUMBER CORRECTED TO 1022819-2011-00011 AS SHOWN.

    Description of Event or Problem · 1

    THE PT CLAIMED THEY WERE BURNED WHEN USING DJO SUPPLIED ELECTRODES WITH A NON DJO ELECTROSTIMULATOR. THE SERIOUSNESS OF THE BURN WAS NOT PROVIDED AND NO MEDICAL INTERVENTION WAS REQUIRED. END USER WAS USING DJO DURA-STICK II ELECTRODES WITH A NON DJO ELECTROSTIMULATOR DEVICE. AS THIS DEVICE WAS NOT RETURNED TO DJO THE FUNCTIONAL CONDITION IS UNK. UNUSED ELECTRODES WERE RETURNED TO DJO AND EVALUATED AND FOUND TO BE FULLY OPERATIONAL. AS DJO CANNOT CONCLUSIVELY DETERMINE IF THE CAUSE OF THE REPORTED EVENT IS DUE TO THE NON DJO ELECTROSTIMULATOR THIS EVENT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURA-STICK II SELF-ADHESIVE ELECTRODES ELECTRODES IPF DJO LLC 4202 915612

    Patients

    Seq Age Sex Outcome Treatment
    1 Other