MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-15 for TEN20 CONDUCTIVE PASTE 10-20 manufactured by D.o. Weaver And Company.
[136452594]
No additional information has been received by the complainant after the initial discussion; we are still attempting to follow up with complainant to see if she has any updated information on the patient's skin irritation. Skin irritation is a known product risk for any topical products, and it is a known fact that some people have sensitive skin that may not react well with certain topical products and/or ingredients of those products. Patient likely experienced some sort of allergic reaction, either from our product (ten20 conductive paste), or some other product used during the eeg study. We will submit a follow up report if we receive additional relevant information pertaining to this adverse event.
Patient Sequence No: 1, Text Type: N, H10
[136452595]
Complainant stated that she had a patient who had severe skin irritation at the electrode sites after a long-term eeg procedure in which ten20 conductive paste was used to attach the electrodes to the patient's skin. The complainant believed that the patient had an allergic reaction to the paste.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1718791-2019-00001 |
| MDR Report Key | 8346336 |
| Date Received | 2019-02-15 |
| Date of Report | 2019-02-15 |
| Date of Event | 2019-01-25 |
| Date Mfgr Received | 2019-01-25 |
| Date Added to Maude | 2019-02-15 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 800119319 |
| Manufacturer Country | US |
| Manufacturer Postal | 800119319 |
| Manufacturer Phone | 3033661804 |
| Manufacturer G1 | D.O. WEAVER AND COMPANY |
| Manufacturer Street | 565 NUCLA WAY, UNIT B |
| Manufacturer City | AURORA 800119319 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 800119319 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TEN20 CONDUCTIVE PASTE |
| Generic Name | NEURODIAGNOSTIC ELECTRODE PASTE |
| Product Code | GYB |
| Date Received | 2019-02-15 |
| Model Number | 10-20 |
| 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 800119319 US 800119319 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-15 |