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

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-14 for EC2 SOME SORT OF GLUE TO ATTACH EEG ELECTRODES TO THE SCALP manufactured by Grass Technologies / Natus Manufacturing Limited..

Event Text Entries

[117430259] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5079145
MDR Report Key7784289
Date Received2018-08-14
Date of Report2018-08-13
Date of Event2018-08-13
Date Added to Maude2018-08-15
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameEC2 SOME SORT OF GLUE TO ATTACH EEG ELECTRODES TO THE SCALP
Generic NameMEDIA, ELECTROCONDUCTIVE
Product CodeGYB
Date Received2018-08-14
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerGRASS TECHNOLOGIES / NATUS MANUFACTURING LIMITED.


Patients

Patient NumberTreatmentOutcomeDate
10 2018-08-14

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