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 10-20 manufactured by D.o. Weaver And Company.
[1961917]
Female patient got ten20 product in the eye. Reported irritation, redness and blurry vision. Went to eye doctor who said there was some injury. Has improved as of (b)(6) 2011, according to reporter/lab manager.
Patient Sequence No: 1, Text Type: D, B5
[8948834]
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 | 1718791-2011-00001 |
| MDR Report Key | 1999228 |
| Report Source | 05,06 |
| Date Received | 2011-02-11 |
| Date of Report | 2011-02-09 |
| Date of Event | 2011-01-12 |
| Date Mfgr Received | 2011-01-18 |
| Date Added to Maude | 2012-05-15 |
| 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 | 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 |
| Manufacturer City | AURORA CO 80015 |
| Manufacturer Country | US |
| Manufacturer Postal | 80015 |
| Manufacturer Phone | 3033661804 |
| Manufacturer G1 | D.O. WEAVER AND COMPANY |
| Manufacturer Street | 565 NUCLA WAY |
| Manufacturer City | AURORA CO 80015 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80015 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TEN20 CONDUCTIVE |
| Generic Name | CONDUCTIVE PASTE |
| Product Code | GYB |
| Date Received | 2011-02-11 |
| Model Number | 10-20 |
| 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 |