MAUDE Adverse Event Report: D. O. WEAVER AND COMPANY TEN20 CONDUCTIVE PASTE; MEDIA, ELECTROCONDUCTIVE

Device Problem Inadequate User Interface (2958)

Patient Problem Corneal Abrasion (1789)

Event Date 10/16/2022

Event Type  Injury  

Event Description

Ten20 paste was used for monitoring leads during a sleep study on patient.Upon return to home while washing paste from hair, patient states the product ran into her eyes resulting in corneal scratching requiring treatment by eye doctor.Fda safety report id# (b)(4).

• Brand Name: TEN20 CONDUCTIVE PASTE
• Type of Device: MEDIA, ELECTROCONDUCTIVE
• Manufacturer (Section D): D. O. WEAVER AND COMPANY; aurora CO 80011 9319
• MDR Report Key: 15843929
• MDR Text Key: 304289148
• Report Number: MW5113402
• Device Sequence Number: 1
• Product Code: GYB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONITORING LEADS
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic