MAUDE Adverse Event Report: NATUS NEUROLOGY, INCORPORATED NATUS GOLD CUP ELECTRODES

Model Number	019-477500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	06/20/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
Electrode size wounds are sometimes found after removing eeg-monitoring electrodes.

• Brand Name: NATUS GOLD CUP ELECTRODES
• Common Device Name: NATUS GOLD CUP ELECTRODES
• Manufacturer (Section D): NATUS NEUROLOGY, INCORPORATED; 3150 pleasant view road; middleton WI 53562
• MDR Report Key: 6638525
• Report Number: 3010611950-2017-00001
• Device Sequence Number: 613996
• Product Code: GXY
• UDI-Device Identifier: 00382830039956
• UDI-Public: 00382830039956
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K072016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 019-477500
• Device Catalogue Number: 019-477500
• Device Lot Number: 027826
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2017
• Initial Report FDA Received Date: 06/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other