NATUS GOLD CUP ELECTRODES 019-477500

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-06-13 for NATUS GOLD CUP ELECTRODES 019-477500 manufactured by Natus Neurology, Incorporated.

Event Text Entries

[77499315] Registered internally as complaint (b)(4), for further investigation by manufacturer. The attending physician indicated that patients were sent home with a balm called flamigel the complaint came to natus (b)(4) as a result of another natus sister facility complaint. The customer completed a questionnaire stating they were seeing skin irritation after eeg monitoring. The customer added (b)(4) part 019477500 to the questionnaire response. We have reached out to the customer on three additional occasions to ask for information and have not received a response. The customer is located in the netherlands. The customer did indicate in the original questionnaire that certain glues and removers were used on the patients, but did not indicate what was being used between the electrode and skin as a conductive, which often impacts skin irritation.
Patient Sequence No: 1, Text Type: N, H10


[77499316] Electrode size wounds are sometimes found after removing eeg-monitoring electrodes.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3010611950-2017-00001
MDR Report Key6638525
Report SourceDISTRIBUTOR
Date Received2017-06-13
Date of Report2017-05-11
Date of Event2016-06-20
Date Mfgr Received2017-05-12
Date Added to Maude2017-06-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. JANESSA BOONE
Manufacturer Street3150 PLEASANT VIEW ROAD
Manufacturer CityMIDDLETON WI 53562
Manufacturer CountryUS
Manufacturer Postal53562
Manufacturer Phone6088298603
Manufacturer G1NATUS NEUROLOGY INCORPORATED
Manufacturer Street3150 PLEASANT VIEW ROAD
Manufacturer CityMIDDLETON WI 53562
Manufacturer CountryUS
Manufacturer Postal Code53562
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNATUS GOLD CUP ELECTRODES
Generic NameNATUS GOLD CUP ELECTRODES
Product CodeGXY
Date Received2017-06-13
Model Number019-477500
Catalog Number019-477500
Lot Number027826
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerNATUS NEUROLOGY, INCORPORATED
Manufacturer Address3150 PLEASANT VIEW ROAD MIDDLETON WI 53562 US 53562


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-06-13

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