BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEN20 CONDUCTIVE PASTE

    MDR report key: 3939196 · Received June 6, 2014

    Report

    Report Number
    1718791-2014-00001
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    April 1, 2014
    Report Date
    May 30, 2014
    Manufacturer
    D.O. WEAVER AND COMPANY
    Product Code
    GYB
    PMA / PMN Number
    K883149
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY REMAINED IN CONTACT WITH PATIENT AFTER THE INCIDENT TO DETERMINE THE STATUS OF THE HAIR LOSS. ON (B)(6) 2014, PATIENT TOLD USER FACILITY THAT ALL OF THE HAIR THAT WAS LOST IS BEGINNING TO REGROW. PATIENT ALSO EMPHASIZED THAT HE BELIEVES HIS HAIR LOSS WAS NOT CAUSED BY THE PROCEDURE OR OUR PRODUCTS. PATIENT IS EXPECTED TO RECOVER COMPLETELY.

    Description of Event or Problem · 1

    USER FACILITY RECENTLY USED NUPREP SKIN PREP GEL AND TEN20 CONDUCTIVE PASTE TOGETHER WITH A NON-INVASIVE ELECTRIC CURRENT STIMULATION DEVICE (TDCS PLUS, NEUROCONN, (B)(6)) AND ENCOUNTERED THE FOLLOWING INCIDENT: A PATIENT LOST ALL HAIR ON THE SPOTS WHERE THE DCS ELECTRODES WERE POSITIONED. IN ORDER TO INDUCE RIGHT HEMISPHERIC FRONTO-CORTICAL DOMINANCE, THE ANODE WAS POSITIONED OVER RIGHT INFERIOR FRONTAL CORTEX (F8), WHILE THE CATHODE WAS POSITIONED OVER LEFT INFERIOR FRONTAL CORTEX (F7). DIRECT CURRENT WAS INDUCED USING A DC-STIMULATOR PLUS AND 5X7CM STANDARD ELECTRODES (NEUROCONN, (B)(6)). ELECTRODES WERE FIXATED USING CONDUCTIVE EEG GEL (TEN20 CONDUCTIVE NEURODIAGNOSTIC ELECTRODE PASTE, WEAVER AND (B)(4)). A 1.5MA DIRECT CURRENT WERE INDUCED FOR A DURATION OF 1500S, INCLUDING RAMPING UP AND DOWN PHASES OF 20S EACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331336 TEN20 CONDUCTIVE PASTE ELECTRODE CONDUCTIVE PASTE GYB D.O. WEAVER AND COMPANY 10-20-XX UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other TDCS PLUS (MFR (B)(4)| NUPREP SKIN PREP GEL