MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-02-11 for TEN20 CONDUCTIVE PASTE 10-20 manufactured by D.o. Weaver And Company.
[1843937]
Male patient got ten20 conductive in eye. Reported irritation, redness, some blurry vision. Not sure he saw a physician. Improved condition on (b)(6), according to (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[9101232]
Evaluation by interview of user lab. They claim to be long time users of product w/o a history of problem. Product is irritating when it gets in the eye. This is a rare event but anticipated. Labeling clearly states to avoid eye contact.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1718791-2011-00002 |
| MDR Report Key | 1999207 |
| Report Source | 05,06 |
| Date Received | 2011-02-11 |
| Date of Report | 2011-02-09 |
| Date of Event | 2011-01-13 |
| Date Mfgr Received | 2011-01-18 |
| Date Added to Maude | 2012-05-14 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAVID WEAVER |
| 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 | EEG CONDUCTIVE PASTE |
| Product Code | GYB |
| Date Received | 2011-02-11 |
| Model Number | 10-20 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | D.O. WEAVER AND COMPANY |
| Manufacturer Address | 565 NUCLA WAY AURORA CO 80011 US 80011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-02-11 |