BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYHESIVE II RETURN ELECTRODE

    MDR report key: 2980462 · Received January 31, 2013

    Report

    Report Number
    1717344-2013-00055
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Date of Event
    December 29, 2012
    Report Date
    January 6, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL INSPECTION OF THE INCIDENT SAMPLE FOUND NO VOIDS ON THE SURFACE OF THE PAD. THE PAD WAS TESTED FOR CONTINUITY AND PASSED. IT WAS NOTED THAT THE PAD GEL WAS DRY AND EXHIBITED HIGH IMPEDANCE DURING TESTING. THIS IS MOST LIKELY DUE TO THE PAD BEING USED AND RETURNED OUTSIDE OF THE PACKAGE. NO CONDITIONS WERE IDENTIFIED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED BURN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PT WAS BURNED AT THE PAD SITE DURING A BELOW THE KNEE AMPUTATION PROCEDURE. DURING THE PROCEDURE, THE REM ALARM SOUNDED. THE NURSE REACHED UNDER THE DRAPE AND PUSHED ON THE REM PAD AND THE ALARM WENT AWAY. THE PAD WAS PLACED ON THE PT'S BUTTOCKS, WITH THE PT FACING UPWARD. UPON COMPLETION OF THE PROCEDURE WHEN THE PAD WAS REMOVED, THE NURSE NOTICED A BURN AT THE PAD SITE. THE BURN WAS VERY MINOR IN NATURE AND TREATED WITH OINTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43611 POLYHESIVE II RETURN ELECTRODE PATIENT RETURN ELECTRODE GEI COVIDIEN LP 225656X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK