MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-03-05 for TEN20 CONDUCTIVE PASTE UNK manufactured by D.o. Weaver And Company.
[21751290]
Patient had eeg performed at heart hospital of florida on (b)(6), 2012. Patient's family later contacted the eeg department stating that the patient had eye irritation/swelling. Family member stated that the patient inadvertently got ten20 paste (that was left in the hair after the procedure) into her eye. Family tried to flush out the eye, but the eye was still irritated.
Patient Sequence No: 1, Text Type: D, B5
[21928200]
Patient saw ophthalmologist, who stated that there was no ten20 paste in the eye. He also stated that there was no damage to the cornea, and that the pain was coming from irritation to the mucus membrane of the eye. Patient was treated with steroid eye drops and pain medication. No permanent damage to the eye is anticipated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1718791-2012-00001 |
| MDR Report Key | 2483443 |
| Report Source | 05 |
| Date Received | 2012-03-05 |
| Date of Report | 2012-02-23 |
| Date of Event | 2012-02-06 |
| Date Mfgr Received | 2012-02-08 |
| Date Added to Maude | 2012-03-09 |
| 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 | TEN20 PASTE |
| Product Code | GYB |
| Date Received | 2012-03-05 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| 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 | 2012-03-05 |