BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEN20 CONDUCTIVE PASTE

    MDR report key: 159776 · Received March 26, 1998

    Report

    Report Number
    1718791-1998-00001
    Event Type
    Injury
    Date Received
    March 26, 1998
    Date of Event
    October 25, 1997
    Report Date
    March 25, 1998
    Manufacturer
    WEAVER AND CO.
    Product Code
    GYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT AN 8 HOUR SLEEP TEST. NEAR THE END OF THE TEST PT WOKE UP WITH EYE IRRITATION. CO'S PRODUCT, TEN20 CONDUCTIVE PASTE HAD RUN FROM THE ELECTRODE AND INTO HIS LEFT EYE. PT SUSTAINED BLURRED VISION FOR SEVERAL WEEKS. OPHTHAMOLOGIST WAS VISITED BY PT AND PRESCRIBED ERYTHROMYCIN DROPS AND VASOCON A FOR TREATMENT. CORNEA WAS BURNED AND IRRITATED AND TEAR DUCTS WERE INFLAMMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEN20 CONDUCTIVE PASTE CONDUCTIVE PASTE FOR NON-DISPOSABLE NEURODIAGNOSTIC ELECTRDS GYB WEAVER AND CO. NA MAR 2000 01

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention