MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-05-16 for TEN20 CONDUCTIVE PASTE 10-20-XX manufactured by D.o. Weaver And Company.
[2720946]
Patient had two eegs conducted, the first in (b)(6) 2011, and the second in (b)(6) 2011. The pt reacted negatively in both instances, but more severly in the first test. The first test, ten20 conductive paste, nuprep skin prep gel, and gold electrodes were used. The electrodes were glued in place with collodion. This test lasted 3 days. After the test, the pt had a severe skin reaction/redness at the electrode sites. During the second test, because the pt reacted negatively when nuprep and ten20 were used, the lab used different products for the test. The pt reacted to this test with redness as well, but not as severe as the first test.
Patient Sequence No: 1, Text Type: D, B5
[9891732]
Lab tech believes pt likely has highly sensitive skin and possibly a "metal allergy" (since nuprep contains aluminum oxide). Reporter also stated that the technologist who administered the test is known to be fairly aggressive when prepping the skin. Because nuprep is abrasive, this may have contributed to the severe reaction in the first test. It is uncertain which products (nuprep, ten20, or the electrodes) caused the reaction.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1718791-2012-00009 |
| MDR Report Key | 2580959 |
| Report Source | 05 |
| Date Received | 2012-05-16 |
| Date of Report | 2012-05-16 |
| Date of Event | 2011-10-01 |
| Date Added to Maude | 2012-05-22 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | NICHOLAS LEE |
| Manufacturer Street | 565 NUCLA WAY, UNIT B |
| Manufacturer City | AURORA CO 80011 |
| Manufacturer Country | US |
| Manufacturer Postal | 80011 |
| Manufacturer Phone | 3033661804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TEN20 CONDUCTIVE PASTE |
| Generic Name | ELECTROCONDUCTIVE MEDIA (CODE: GYB) |
| Product Code | GYB |
| Date Received | 2012-05-16 |
| Model Number | 10-20-XX |
| Catalog Number | 10-20-XX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | D.O. WEAVER AND COMPANY |
| Manufacturer Address | AURORA CO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-05-16 |