BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONE

    MDR report key: 608474 · Received April 25, 2005

    Report

    Report Number
    2022388-2005-00001
    Event Type
    Other
    Date Received
    April 25, 2005
    Date of Event
    February 1, 2005
    Report Date
    April 20, 2005
    Manufacturer
    THE ELECTRODE STORE, INC.
    Product Code
    DRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    GOLD-PLATED COPPER EEG DISC ELECTRODES USED WITH LEMON PREP (CORPORATION), SIGNA GEL (LABORATORIES), AND COLLODION (MANUFACTURER UNK). SKIN PREPARATION AND ELECTRODE ATTACHMENT PROCEDURES UNK. ELECTRODES USED ON THREE PTS FOR THREE DAYS, RESULTING IN MINOR HEAD SORES TREATED TOPICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE EEG ELECTRODE SET DRX THE ELECTRODE STORE, INC. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other