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

Model Number 10-20-4T

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

Patient Problem Eye Pain (4467)

Event Date 10/15/2022

Event Type  Injury  

Event Description

On (b)(6) 2022 a 60 year old female patient at musc had an overnight sleep study conducted.Ten20 paste was used for monitoring leads during the study.The study was completed per procedure without issue and the patient was sent home.Upon return home, while washing the product from hair, the patient stated the product ran into her eyes resulting in corneal scratching requiring treatment by an eye doctor.

Manufacturer Narrative

On (b)(6) 2022, weaver and company received notification via email from (b)(6) director of risk management and patient safety at musc making us aware that a voluntary adverse event report was submitted that morning to maude.Ms.Ebersole sent an email stating "please see the attached letter regarding an injury reported to our organization that the patient alleges is secondary to your product".The letter provided the patients narrative, "upon return home, while washing paste from hair, patient states the product ran into her eyes resulting in corneal scratching requiring treatment by eye doctor", along with the statement: "we are unable to conclude the actual mechanism of injury as the product being water soluble and a possible irritant that may have flowed into her eyes while washing her hair, or if the alleged injury was secondary to rubbing of the eyes by the patient.This product is routinely used in our facility, was used in the usual manner as intended, with no known or suspected contact with the eyes during the course of the study, and no similar reaction or outcome has previously been reported to us." weaver and company followed up via email to furnish additional information.Weaver and company followed up again via phone and was able to get in contact with ms.Ebersole, who provided additional information about the event and the medwatch report to weaver via email after the phone conversation.Ms.(b)(6) followup email stated: "thank you for reaching out and speaking with me this afternoon.As discussed, the statement provided by the patient is included below: 'pt states she had a recent sleep study.She states whatever they placed in her head ran in her eyes and scratched her cornea.She states no one removed the stuff from her head or told her to wash it off.Pt states she has sought care with an ophthalmologist (non-musc).Pt states she is unable to see, can't drive and has very cloudy vision, and unable to work.States she is only able to maneuver in her home.She states if this does not resolve she will be expecting her bills to be paid for her eye appointments, prescriptions and employment wages for missed work.' she did supply her eye doctor progress notes to us.Her report to their office noted she had a sleep study done the night prior to the visit and everything was fine in the a.M.After working out sweat dripped in eyes and was burning, had probes on head and thinks something from that dripped in eyes.She self-treated with visine and sodium chloride for fuchs prior to her eye doctor visit.All treatment appears to be related to dry eye syndrome.I will reach back out to update you regarding the availability of the lot number once i hear back from the department manager." mw#: (b)(4).After discussion with ms.Ebersole, it appears that the complainant did not immediately shower upon return home to remove the product from her hair and still had probes on the head.Sweat from working out seemed to trigger the event and the complainant attempted to self-treat her injuries with over the counter products before contacting an eye doctor.The eye doctor progress notes indicate the patient was treated for dry eye syndrome rather than corneal scratching.No additional follow up progress has been provided to weaver or musc after the initial visit.As such we have decided to file this mdr despite having limited information on the severity of the injury, current status of the injury and the actual mechanism of injury from a healthcare professional.If we receive additional relevant information, a followup report will be submitted.

• Brand Name: TEN20 CONDUCTIVE PASTE
• Type of Device: ELECTRODE CONDUCTIVE 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 a; aurora CO 80011 9319
• Manufacturer Contact: daniel pincus ; 565 nucla way; unit b; aurora, CO 80011-9319 ; 3033661804
• MDR Report Key: 16000270
• MDR Text Key: 305687530
• Report Number: 1718791-2022-22001
• Device Sequence Number: 1
• Product Code: GYB
• UDI-Device Identifier: 00891893002239
• UDI-Public: 00891893002239
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K883149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/15/2022

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
• Device Model Number: 10-20-4T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2022
• Initial Date FDA Received: 12/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 60 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White