MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-02-10 for TEN20 CONDUCTIVE PASTE 10-20-XX manufactured by D. O. Weaver And Company.
[67208525]
Attempted contact with patient on feb 3, 2017, feb 7, 2017, and feb 9, 2017. Patient did not answer phone. Voicemail left on feb 3rd, but not return call. Could not leave voicemail on next two attempts due to patient's voicemail box being full. It is a known fact that a very small percentage of the population will react negatively to topical products. Based on the information provided, patient may have experienced an allergic reaction to ten20. Without further information, we cannot determine a more definitive cause. It additional information becomes available, we will file a follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[67208526]
Pt called jan 10, 2017 regarding an injury she sustained during an eeg that was performed on her on (b)(6) 2016. Following the eeg, pt claims she was not allowed to wash her hair. As a result, she developed an itchy scalp that later spread down the back of her neck and onto her shoulders. She was told that ten20 was used during her eeg. She contacted her pharmacist, who provided her with a list of ingredients in ten20, but stated that none of them should develop a general area of itchiness. She made an appointment with her primary care physician, which took place (b)(6) 2017. We told her we would call her back after her appointment to ascertain progress.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1718791-2017-00001 |
| MDR Report Key | 6323829 |
| Report Source | CONSUMER |
| Date Received | 2017-02-10 |
| Date of Report | 2017-02-10 |
| Date of Event | 2016-09-22 |
| Date Mfgr Received | 2017-01-10 |
| Date Added to Maude | 2017-02-10 |
| 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 |
| 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 | 2017-02-10 |
| Model Number | 10-20-XX |
| Catalog 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 | 2017-02-10 |