BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIHON KOHDEN NE-136A ELECTRODE

    MDR report key: 1052137 · Received May 23, 2008

    Report

    Report Number
    MW5007018
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    April 22, 2008
    Report Date
    May 23, 2008
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    GWQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IN 2008, SALE REPRESENTATIVE HAD A PHONE CONVERSATION WITH THE USER FACILITY. SHE SAID THAT THE HOSP LAB HAD STOPPED USING NIHON KOHDEN EEG ELECTRODES. SHE STATED THAT THE ELECTRODES WERE CAUSING BRUISING ON A NUMBER OF PATIENTS. THE FACILITY HAS SINCE BEGUN USING ANOTHER MFR'S ELECTRODES, MADE A FEW CHANGES TO THEIR "HOOK UP" OF THE PATIENTS AND THE PROBLEM HAS NOT REPRODUCED ITSELF. IT WAS THE EEG TECH'S IMPRESSION THAT THE NK PROVIDED ELECTRODES WERE THE CAUSE OF THE PROBLEM, NOT THE "HOOK UP" PROCEDURE. HOWEVER, THERE WAS NO DETAIL INFO REGARDING THE "HOOK UP" PROCEDURE OR THE USAGE OF EEG GELS WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIHON KOHDEN NE-136A ELECTRODE NONE GWQ NIHON KOHDEN CORPORATION NE-136A NA

    Patients

    Seq Age Sex Outcome Treatment
    1