MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-04-04 for TEN20 CONDUCTIVE PASTE UNK manufactured by D.o. Weaver And Co..
[15857925]
Pt underwent a sleep study on (b)(6) 2012. Following the test, he went to the gym for a work out. His perspiration reportedly mixed with the eeg paste and dropped into his eyes, causing redness and irritation in both eyes. The pt went to an ophthalmologist who diagnosed him with chemical conjunctivitis. Pt complained of blurred vision and pain. He was treated with eye drops and antibiotics. Although symptoms improved as of (b)(6) 2012, pt continues to complain of symptoms and is receiving medical follow-up.
Patient Sequence No: 1, Text Type: D, B5
[15870796]
We have been awaiting an update from the follow-up the pt was receiving, but have yet to receive any updates. If we receive additional pertinent info regarding this complaint, we will submit a follow-up report to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1718791-2012-00003 |
| MDR Report Key | 2526444 |
| Report Source | 05 |
| Date Received | 2012-04-04 |
| Date of Report | 2012-04-02 |
| Date of Event | 2012-02-16 |
| Date Mfgr Received | 2012-03-05 |
| Date Added to Maude | 2012-04-12 |
| 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 | RISK MANAGER |
| 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 | TEN20 PASTE |
| Product Code | GYB |
| Date Received | 2012-04-04 |
| Model Number | UNK |
| Catalog Number | UNK |
| 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 CO. |
| Manufacturer Address | AURORA CO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-04-04 |