BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EC2 SOME SORT OF GLUE TO ATTACH EEG ELECTRODES TO THE SCALP

    MDR report key: 7784289 · Received August 14, 2018

    Report

    Report Number
    MW5079145
    Event Type
    Injury
    Date Received
    August 14, 2018
    Date of Event
    August 13, 2018
    Report Date
    August 13, 2018
    Manufacturer
    GRASS TECHNOLOGIES / NATUS MANUFACTURING LIMITED.
    Product Code
    GYB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2018, I HAD A 3 DAY AMBULATORY EEG PLACED ON ME AS SCHEDULED AT A NEUROLOGY OFFICE I HAVE VISITED - (B)(6). UPON HAVING THE ELECTRODES GLUED ON ME, I FELT A THROBBING SENSATION AND A BIT OF AN ITCH AND A SLIGHT PAIN, BUT WAS TOLD THAT WAS NORMAL. THE THROB WAS NOT A PAINFUL, JUST A THROBBING SENSATION. THROUGHOUT THE WEEKEND, MY HEAD ITCHED AND HAD SOME SLIGHT PAIN, BUT THAT WAS ABOUT IT. TODAY, ((B)(6) 2018), I WENT INTO THE DR'S OFFICE AND THEY REMOVED THE EEG ELECTRODES AND THEY WERE STUNNED AT WHAT APPEARED TO BE A SERIOUS ALLERGIC REACTION. VERY NASTY, RED, SERIOUS LOOKING MARKS ALL OVER MY FOREHEAD AND THE TOP OF MY HEAD - VERY SERIOUS LOOKING AND QUITE UNSIGHTLY. THEY STATED THAT THEY BELIEVED THIS COULD HAVE ONLY BEEN CAUSED BY THE GLUE OR PASTE THAT WAS USED TO ATTACH THE ELECTRODES TWO TECHS IN THIS OFFICE AND BOTH STATED THEY HAVE SEEN ALLERGIC REACTIONS TO THESE TYPE OF SITUATIONS BEFORE, BUT NEVER ONE THAT LOOKED AS BAD AS MINE. I HAVE NOT GONE TO A DR YET, ALTHOUGH I DID REQUEST THE NEUROLOGIST AT THAT DR'S OFFICE TO AT LEAST LOOK AT IT, BUT THE TECH CALLED ME BACK AND STATED THAT THE NEUROLOGIST SAID TO TAKE BENADRYL AND IF IT GOT WORSE TO GO TO A PRIMARY CARE DOCTOR. OBVIOUSLY EC2 CAUSED THIS ALLERGIC REACTION, BUT I AM UNABLE TO FIND OUT WHAT THE INGREDIENTS ARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621007 EC2 SOME SORT OF GLUE TO ATTACH EEG ELECTRODES TO THE SCALP MEDIA, ELECTROCONDUCTIVE GYB GRASS TECHNOLOGIES / NATUS MANUFACTURING LIMITED.

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR