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 2016-10-19 for TEN20 CONDUCTIVE PASTE 10-20-XX manufactured by D. O. Weaver And Company.
[57845474]
Reporter called on oct 14, 2016 to state that the pt's eyes had improved and that there would be no permanent injury to the eye. They have not been able to determine for sure what caused the eyes to become irritated, but we believe that the ten20 paste may have indeed got into the eyes and remained there while the pt was in a somewhat comatose state, causing the irritation. Device labeling clearly states to avoid eye contact because it is known that it can cause irritation to the eyes if it comes into contact with them. Device not available for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[57845475]
Received email from pediatric neurophysiology supervisor on oct 5, 2016 regarding a (b)(6) male pt who had experienced corneal abrasion due to chemical burn. Pt was historically under induced comatose condition, but recently partially revived to a neurologically sedated condition. Pt had eeg electrodes with ten20 conductive paste under the electrodes and collodion used with gauze to hold the electrodes in place at fp1 and fp2 locations above the eyes on the forehead. Supervisor believes ten20 paste may have melted and ran into the pt's eyes and remained there a while, causing the chemical burn which resulted in corneal abrasion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1718791-2016-00002 |
| MDR Report Key | 6040452 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-10-19 |
| Date of Report | 2016-10-19 |
| Date of Event | 2016-10-04 |
| Date Mfgr Received | 2016-10-05 |
| Date Added to Maude | 2016-10-19 |
| 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 | MEDICAL TECHNOLOGIST |
| 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 | 2016-10-19 |
| Model Number | 10-20-XX |
| Operator | NURSE |
| 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 | 2016-10-19 |