BEUDAMED
    FDA Adverse Event Other Summary report: N

    TEN 20

    MDR report key: 780719 · Received October 27, 2006

    Report

    Report Number
    3003418325-2006-00024
    Event Type
    Other
    Date Received
    October 27, 2006
    Date of Event
    July 19, 2006
    Report Date
    October 25, 2006
    Manufacturer
    WEAVER & CO
    Product Code
    GWQ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTED TO AN INTEGRA PRODUCT MFR A REACTION TO THE PRODUCT OCCURRED . WHEN THE PRODUCT HAD BEEN APPLIED TO THE PT'S SKIN FOR SOME EEG TESTING, THE PT EXPERIENCED SKIN IRRITATION AND BLISTERING. THOUGH NO PRODUCT CATALOG NUMBER COULD BE OBTAINED FROM THE PT, SHE DID PROVIDE A BRAND NAME, TEN 20. THREE POSSIBLE PRODUCT IDENTIFICATIONS; M047, M048, M050, ARE ASSOCIATED WITH THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEN 20 EEG CONDUCTIVE ADHESIVE GWQ WEAVER & CO * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other