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

Model Number	10-20-8
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Pain (4467)
Date of Event	12/19/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: NEURODIAGNOSTIC ELECTRODE PASTE
• Manufacturer (Section D): D.O. WEAVER AND COMPANY; 565 nucla way, unit b; aurora CO 80011 9319
• MDR Report Key: 11208390
• Report Number: 1718791-2021-00001
• Device Sequence Number: 4140112
• Product Code: GYB
• UDI-Device Identifier: 00891893002239
• UDI-Public: (01)00891893002239(17)230101(10)1141
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K883149A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 01/21/2021
• 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
• Patient Age: 54 YR