BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLATINUM SUBDERMAL ELECTRODES F-EZ 48"

    MDR report key: 3736706 · Received April 1, 2014

    Report

    Report Number
    3736706
    Event Type
    Other
    Date Received
    April 1, 2014
    Date of Event
    March 18, 2014
    Report Date
    March 31, 2014
    Product Code
    GXZ
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THREE BURNS NOTED WHEN DRAPES REMOVED AFTER SURGERY DURING WHICH SUBDERMAL ELECTRODES WERE PLACED IN THESE AREAS OF FACE AND 2 AREAS ON UPPER STERNUM. PT HAD INTRAOPERATIVE MRI WITH LEADS IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196418 PLATINUM SUBDERMAL ELECTRODES F-EZ 48" NONE GXZ

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other