MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2011-05-03 for TEN20 CONDUCTIVE PASTE 8OZ 10-20-8 manufactured by D.o. Weaver And Co..
[1986963]
Female pt was being treated with biofeedback/eeg by clinician. Site or sites on scalp developed infection, possibly (b)(6) infection.
Patient Sequence No: 1, Text Type: D, B5
[9125003]
We reviewed the device history file. No other injury complaints from this lot of product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1718791-2011-00004 |
| MDR Report Key | 2086536 |
| Report Source | 05,08 |
| Date Received | 2011-05-03 |
| Date of Report | 2011-05-03 |
| Date of Event | 2011-04-05 |
| Date Mfgr Received | 2011-04-05 |
| Device Manufacturer Date | 2010-06-15 |
| Date Added to Maude | 2011-05-16 |
| 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 |
| 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 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 8OZ |
| Generic Name | TEN20 CONDUCTIVE PASTE 8 OZ |
| Product Code | GYB |
| Date Received | 2011-05-03 |
| Model Number | 10-20-8 |
| Catalog Number | 10-20-8 |
| Lot Number | 665 |
| ID Number | NA |
| Device Expiration Date | 2012-07-01 |
| 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 CO. |
| Manufacturer Address | AURORA CO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-05-03 |