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

Model Number 10-20-8

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

Patient Problem Eye Pain (4467)

Event Date 12/19/2020

Event Type  Injury  

Manufacturer Narrative

Employee from sleep center called regarding a patient of theirs rinsing ten20 conductive paste out of hair and it got in the patient's eye, causing irritation.Employee asked if there was any suggestion for patient or medication to recommend.We told the complainant the following, as stated in the "cautions" section of the device's ifu: "avoid eye contact.If product is introduced in the eye, rinse with warm water for 10 to 15 minutes.Avoid rubbing the eyes." sleep center employee stated that their patient has made an appointment with their physician.We have attempted to followup with the complainant numerous times to determine how that patient is doing.We have been unsuccessful in obtaining this information.As such, we have decided to err on the side of caution and file this mdr, despite having no information as to the severity of the injury and what the current status of the patient's injury is.If we receive additional relevant information, we will submit a followup report.

Event Description

Employee from sleep center called regarding a patient of theirs rinsing ten20 conductive paste out of hair and it got in the patient's eye, causing irritation.Sleep center employee stated that their patient has made an appointment with their physician.

• 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 CO 80011 9319
• Manufacturer (Section G): D.O. WEAVER AND COMPANY; 565 nucla way, unit b; aurora CO 80011 9319
• Manufacturer Contact: nicholas lee ; 565 nucla way, unit b; aurora, CO 80011-9319 ; 3033661804
• MDR Report Key: 11208390
• MDR Text Key: 228004670
• Report Number: 1718791-2021-00001
• Device Sequence Number: 1
• Product Code: GYB
• UDI-Device Identifier: 00891893002239
• UDI-Public: (01)00891893002239(17)230101(10)1141
• 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: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/21/2021

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: Lay User/Patient
• Device Expiration Date: 01/01/2023
• Device Model Number: 10-20-8
• Device Lot Number: 1141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 01/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR