MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-05-18 for TEN20 CONDUCTIVE PASTE 10-20-XX manufactured by D. O. Weaver And Company.
[75447624]
Multiple follow-up attempts with complainant have been unsuccessful. However, it is a known fact that a small percentage of the population have sensitive skin and/or experience irritation from topical products, especially when the topical products are left on the skin for multiple days. Device labeling clearly states that electrode sites should be checked daily if the electrodes are going to be attached for a long period of time. If we receive any additional relevant information about this incident, we will file a follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[75447625]
Pt's mother called to report that her soon had an ambulatory eeg from (b)(6) through (b)(6) 2017 while he was at home with his mother. On sunday, pt mentioned to his mom that there was some stinging sensation at a few of the electrode sites. Then on monday, the mother reported that she saw some oozing behind pt's left ear, as well as redness on the forehead where electrodes were attached. Pt's mom proceeded to take pt to his pcp where he was prescribed baby shampoo, neosporin, and tylenol for pain. Pcp believes that permanent scarring is possible.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1718791-2017-00004 |
| MDR Report Key | 6575419 |
| Report Source | CONSUMER |
| Date Received | 2017-05-18 |
| Date of Report | 2017-05-18 |
| Date of Event | 2017-04-17 |
| Date Mfgr Received | 2017-04-18 |
| Date Added to Maude | 2017-05-18 |
| 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 | PATIENT FAMILY MEMBER OR FRIEND |
| 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 | 2017-05-18 |
| Model Number | 10-20-XX |
| Operator | MEDICAL TECHNOLOGIST |
| 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 | 2017-05-18 |