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

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Corneal Abrasion (1789)

Event Date 10/16/2022

Event Type  Injury  

Event Description

Patient had a recent sleep study where ten20 conductive paste was used.Patient called stating when she went home and washed her hair, the paste got in her eyes and she now has a scratched cornea requiring treatment with an ophthalmologist.

• Brand Name: TEN20 CONDUCTIVE PASTE
• Type of Device: MEDIA, ELECTROCONDUCTIVE
• Manufacturer (Section D): D.O. WEAVER AND COMPANY
• MDR Report Key: 15761259
• MDR Text Key: 303549631
• Report Number: MW5113193
• 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: 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female