BEUDAMED
    FDA Adverse Event Other Summary report: N

    1310P MEDITRACE DEFI/PACING EL X20

    MDR report key: 3230051 · Received July 12, 2013

    Report

    Report Number
    9681860-2013-00017
    Event Type
    Other
    Date Received
    July 12, 2013
    Report Date
    July 9, 2013
    Manufacturer
    COVIDIEN
    Product Code
    DRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2013 THAT A CUSTOMER HAD AN ISSUE WITH DEFIBRILLATION ELECTRODES. THE CUSTOMER REPORTS THAT SOME BURNT TYPE REDNESS WAS NOTICED ON THE PATIENT'S SKIN AFTER BEING IN CONTACT WITH THE SENSORS. IN SOME AREAS, THERE WAS ONLY PARTIAL REDNESS BUT IN OTHER AREAS THE WHOLE SURFACE OF THE SENSOR LEFT A RED MARK ON THE SKIN. THE BURN APPEARED TO BE A 1ST DEGREE BURN, SUNBURNT TYPE UNDER THE STICKER, AND 2ND DEGREE AROUND THE EDGE OF THE STICKER. THERE WAS MORE SEVERE REDNESS AND BLISTERING AROUND THE STICKER. IT WAS STIFF ON THE EDGE OF THE STICKER AND APPEARED TO BE DRY. THE PATIENT WAS GIVEN BIAFINE CREAM BY A PHYSICIAN TO TREAT THE BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324061 1310P MEDITRACE DEFI/PACING EL X20 DEFIBRILLATION ELECTRODES DRX COVIDIEN 31319281 134707

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other