BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYHESIVE II RETURN ELECTRODE

    MDR report key: 1833943 · Received September 2, 2010

    Report

    Report Number
    1717344-2010-00606
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    July 30, 2010
    Report Date
    August 9, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE, THE INCIDENT SAMPLE HAS NOT BEEN RETURNED FOR EVAL. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THREE PTS SUFFERED BURNS AT THE RETURN ELECTRODE SITE. THE DEGREE OF BURN AND PT INFO WAS NOT REPORTED. PLEASE REFERENCE REPORTS 1717344-2010-00605 AND 1717344-2010-00607 FOR THE OTHER TWO INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYHESIVE II RETURN ELECTRODE PATIENT RETURN ELECTRODE GEI COVIDIEN LP (VALLEYLAB) 175947

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK