MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2015-10-14 for TEN20 CONDUCTIVE PASTE 10-20-XX manufactured by D. O. Weaver And Company.
[28141922]
Most likely cause of injury is that the ten20 conductive paste entered the eye while being washed out of the patient's hair. Ten20 conductive paste is water-soluable, so washing the hair with warm water is the best method to remove traces of the product left in the hair. However, as the water ran off the patients hair and down her face, some must have inadvertently came in contact with the patient's cornea, causing a reaction. Some traces of nuprep skin prep gel, the gel used to prepare electrode sites prior to placing electrodes on the patient, may also have been present in the hair and traveled with the water into the patient's eyes. Nuprep gel contains aluminum oxide, which is abrasive, and would certainly cause irritation of the eye upon contact. Product is clearly labeled "avoid eye contact". Of all patients that have reported eye irritation from ten20 conductive paste and/or nuprep skin prep gel, none have reported permanent damage to eyes and/or eyesight. Device not available to be returned.
Patient Sequence No: 1, Text Type: N, H10
[28141923]
Pt had sleep study where ten20 conductive paste and nuprep skin prep gel were used. Pt called user facility's patient relations department on (b)(6) 2015 to report damage to eyes after she washed her hair. Pt stated that her eyes began to burn and became extremely red, her vision was blurry, and was experiencing pain in her eyes. She went to her eye physician and was told she had a severe allergic reaction. She stated that the doctor told her he was not sure if she would get her eye sight back due to damage. On (b)(6) 2015 pt's vision was 20/80 in both eyes. Treatment plan was systane balance eye drops every 1-2 hours, both eyes, while awake and prednisolone acetate eye drops 4 times per day, both eyes. Patient was advised to return to the office in 2 days and that vision will likely improve when inflammation is reduced. On (b)(6) 2015, patient reported that left eye felt great, while the right eye still burned a little but other than that, felt okay. Patient injury diagnosed as "superficial keratitis unspecified".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1718791-2015-00002 |
| MDR Report Key | 5147425 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2015-10-14 |
| Date of Report | 2015-09-15 |
| Date of Event | 2015-08-18 |
| Date Mfgr Received | 2015-09-15 |
| Date Added to Maude | 2015-10-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. NICHOLAS LEE |
| Manufacturer Street | 565 NUCLA WAY, UNIT B |
| Manufacturer City | AURORA CO 80011 |
| Manufacturer Country | US |
| Manufacturer Postal | 80011 |
| Manufacturer Phone | 3033661804 |
| Manufacturer G1 | D. O. WEAVER AND COMPANY |
| Manufacturer Street | 565 NUCLA WAY, UNIT B |
| Manufacturer City | AURORA CO 80011 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80011 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TEN20 CONDUCTIVE PASTE |
| Generic Name | NEURODIAGNOSTIC ELECTRODE PASTE |
| Product Code | GYB |
| Date Received | 2015-10-14 |
| Model Number | 10-20-XX |
| Catalog Number | 10-20-XX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | D. O. WEAVER AND COMPANY |
| Manufacturer Address | 565 NUCLA WAY, UNIT B AURORA CO 80011 US 80011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-10-14 |