BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATINUM SUBDERMAL ELECTRODES F-EZ 48"

    MDR report key: 3736724 · Received April 1, 2014

    Report

    Report Number
    3736724
    Event Type
    Injury
    Date Received
    April 1, 2014
    Report Date
    March 31, 2014
    Product Code
    GXZ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN DRAPES REMOVED AFTER 18 DEGREES PROCEDURE SMALL RED SPOT NEAR SIDE OF MOUTH AND SMALL SPOT NEAR CENTER OF UPPER CHEST. PT HAD SUBDERMAL LEADS IN PLACE ON THAT AREA OF THE FACE. RN IS UNCERTAIN IF PT HAD LEAD ON CHEST PT HAD INTRAOPERATIVE MRI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196485 PLATINUM SUBDERMAL ELECTRODES F-EZ 48" NONE GXZ

    Patients

    Seq Age Sex Outcome Treatment
    1 Other