MAUDE Adverse Event Report: D.O. WEAVER AND COMPANY TEN20 CONDUCTIVE PASTE; NEURODIAGNOSTIC ELECTRODE PASTE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Irritation (2076)

Event Date 05/25/2020

Event Type  Injury  

Manufacturer Narrative

Contacted initial reporter, the risk manager at (b)(6).She stated that they were notified some time after the incident, but she had no information as to severity or current patient condition.Contacted the hospital and spoke with the eeg department manager.He stated he had only been the manager for 2 weeks, so he was not directly involved in with the incident.He said that an experienced tech had applied electrodes without previous or subsequent issues.The only information he was able to provide about the patient was that he/she was pediatric.He said he would try to contact the previous manager to get additional information.As of this report, he has not provided any additional information.If we receive additional pertinent information regarding this incident, we will submit a follow-up report to fda.

Event Description

Received medwatch report mw5094901 from fda on 6/30/2020.Report stated: "eeg performed for a recording duration of 20:06 minutes utilizing nuprep, ten20 paste, and gauze pads.No tape was used.Wound care reported 'multiple areas to forehead with possible breakdown from eeg performed since admission due to chemical burns'.".

• Brand Name: TEN20 CONDUCTIVE PASTE
• Type of Device: NEURODIAGNOSTIC ELECTRODE PASTE
• Manufacturer (Section D): D.O. WEAVER AND COMPANY; 565 nucla way, unit b; aurora,
• Manufacturer (Section G): D.O. WEAVER AND COMPANY; 565 nucla way, unit b; aurora,
• Manufacturer Contact: nicholas lee ; 565 nucla way, unit b; aurora, ; 3661804
• MDR Report Key: 10344335
• MDR Text Key: 201162393
• Report Number: 1718791-2020-00003
• Device Sequence Number: 1
• Product Code: GYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K883149A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/30/2020

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/30/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5 YR