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

Model Number 10-20-XX

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

Patient Problem Skin Irritation (2076)

Event Date 05/26/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6) child, approximately (b)(6) years old female had been to (b)(6) hospital at (b)(6) for a 72 hour eeg monitoring evaluation.The moss child has shown signs of autism and is easily agitated.(b)(6) child had a 40 minute eeg when she was approximately (b)(6) months old and there was no skin reaction when that eeg evaluation was completed.(b)(6), mother of (b)(6) child sent via email five pictures of the (b)(6) child clearly showing redness and irritation, with possible scarring at the electrode sites fp1 and fp2 as well as what looks like a ground electrode on the forehead.(b)(6) reports that there was a similar irritation near one ear that was not in the photos provided.I have referred (b)(6) to the aset video explaining skin safety.This is available using this link to video available on the aset website.Https://www.Aset.Org/i4a/pages/index.Cfm?pageid=4161.Click arrow to start, then go to the 3 line selection above the speakers head and choose technique.When the second speaker finishes, choose stretch gauze.This explains that non-stretchable tape and tight wrapping for long term monitoring is discouraged.The pictures provided by (b)(6) clearly show injury from the position of the electrode itself as well as the tail.If this were a reaction to paste, you would expect an injury this well defined to be at the point of contact with paste.This injury shows damage from the electrode perimeter as well as the "tail" or electrode wire leading to the electrode.(b)(6) said that the technologists wrapped the head with gauze and then with non-stretchable tape.I told her that informal guidelines are, when using a wrap, is to wrap the head loosely and not use non-stretchable tape.The idea is to wrap the head loosely enough that a person could put two fingers under the wrap.She said that it would not be possible to place two fingers under the wrap.Angel moss said that this procedure was to be a 72 hour test, but the patient suffered discomfort and they discontinued the procedure and took off the electrodes after approximately 4 hours.According to (b)(6), one physician said that it could have been an electrode malfunction.I disagree.The irritation/scarring occurred both in the exposed electrode area as well as the insulated tail of the electrode.As highly unlikely as it is that the eeg machine produced a current, it is even less likely that it produced a current along the insulated tail.Another physician said it looked like a chemical burn.Again, i would suggest that there is another explanation.This irritation is very clearly defined at the electrode site, where there is paste, as well as along the tail of the electrode, where there is no paste.Given the explanation by (b)(6) and by reviewing the photos send to her, i would suggest that the head was wrapped tightly and bandaged in such a way as to put pressure on the sites.The patient has certain health issues and this along with the application method probably caused the irritation.We have not talked with (b)(6) hospital at this writing.From our perspective it looks as though a sensitive patient had electrodes applied and covered with a bandage too tight for her particular skin condition.Fortunately the procedure was terminated appropriately and the patient is likely to recover with no permanent scarring.

Event Description

Mother took (b)(6) year old daughter in for a 72 hour eeg test to (b)(6) hospital in (b)(6) on tuesday (b)(6).Daughter is autistic and suffers severe anxiety.Daughter had a previous eeg test at same location and did not suffer any reactions.Test on tuesday (b)(6) resulted in 3 "burns" on forehead and 1 above ear.Mother took daughter home after one night because she was too fussy to stay any longer.Wednesday night the forehead looked like bruises under the adhesive.Once she washed child, she saw the burn marks.Angel called the hospital and doctor said is was a chemical burn or reaction to gold disposal electrodes.Then on friday, (b)(6), she took child to her pediatrician who said it could be an electrode malfunction.Mother has been treating child with silver sulfate for burns.Procedure used on child was cleaned area with a green scrubby, applied electrode with paste, taped over electrode, wrapped head in gauze and taped gauze.

• 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,
• Manufacturer (Section G): D.O. WEAVER AND COMPANY; 565 nucla way, unit b; aurora,
• Manufacturer Contact: nicholas lee ; 565 nucla way, unit b; aurora, ; 3661804
• MDR Report Key: 10224720
• MDR Text Key: 201362017
• Report Number: 1718791-2020-00001
• Device Sequence Number: 1
• Product Code: GYB
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/02/2020

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-XX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/04/2020
• Initial Date FDA Received: 07/02/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR