MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-11-03 for TEN20 CONDUCTIVE PASTE 10-20-8 manufactured by D.o. Weaver And Co..
[18128555]
Female pt had eeg performed. Afterwards, pt complained of hair loss at front electrode sites.
Patient Sequence No: 1, Text Type: D, B5
[18200313]
Eval and investigation by interview of lab. No other complaints associated with this lot. Most likely cause is the fact that the pt had so much in the way of treatments and processing combined with the eeg procedure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1718791-2011-00006 |
| MDR Report Key | 2343942 |
| Report Source | 05,06 |
| Date Received | 2011-11-03 |
| Date of Report | 2011-11-02 |
| Date of Event | 2011-10-28 |
| Date Mfgr Received | 2011-10-31 |
| Device Manufacturer Date | 2011-01-01 |
| Date Added to Maude | 2012-07-16 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TEN20 CONDUCTIVE PASTE |
| Generic Name | TEN20 CONDUCTIVE PASTE |
| Product Code | GYB |
| Date Received | 2011-11-03 |
| Model Number | 10-20-8 |
| Catalog Number | 10-20-8 |
| Lot Number | 996 |
| Device Expiration Date | 2014-01-31 |
| 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. Other | 2011-11-03 |