BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATINUM SUBDERMAL ELECTRODES F-EZ 48" NEEDLE

    MDR report key: 3736683 · Received April 1, 2014

    Report

    Report Number
    3736683
    Event Type
    Injury
    Date Received
    April 1, 2014
    Date of Event
    August 6, 2013
    Report Date
    March 31, 2014
    Product Code
    GXZ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TWO SKIN BURNS NOTED AT END OF OPERATING ROOM PROCEDURE NEAR SITE OF INTRAOPERATIVE NEURO MONITORING LEADS - PT UNDERWENT INTRAOP MRI WITH THESE SUBDERMAL PLATINUM LEADS IN PLACE, FOR INTRAOPERATIVE NEURO MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196790 PLATINUM SUBDERMAL ELECTRODES F-EZ 48" NEEDLE NONE GXZ

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other