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

Model Number 10-20

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Skin Erosion (2075); Skin Irritation (2076)

Event Date 01/25/2019

Event Type  Injury  

Manufacturer Narrative

No additional information has been received by the complainant after the initial discussion; we are still attempting to follow up with complainant to see if she has any updated information on the patient's skin irritation.Skin irritation is a known product risk for any topical products, and it is a known fact that some people have sensitive skin that may not react well with certain topical products and/or ingredients of those products.Patient likely experienced some sort of allergic reaction, either from our product (ten20 conductive paste), or some other product used during the eeg study.We will submit a follow up report if we receive additional relevant information pertaining to this adverse event.

Event Description

Complainant stated that she had a patient who had severe skin irritation at the electrode sites after a long-term eeg procedure in which ten20 conductive paste was used to attach the electrodes to the patient's skin.The complainant believed that the patient had an allergic reaction to the paste.

• 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 80011 9319
• Manufacturer (Section G): D.O. WEAVER AND COMPANY; 565 nucla way, unit b; aurora 80011 9319
• Manufacturer Contact: nicholas lee ; 565 nucla way, unit b; aurora 80011-9319 ; 3033661804
• MDR Report Key: 8346336
• MDR Text Key: 136452594
• Report Number: 1718791-2019-00001
• Device Sequence Number: 1
• Product Code: GYB
• 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: 02/15/2019

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2019
• Initial Date FDA Received: 02/15/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR