MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-04-18 for TEN20 CONDUCTIVE PASTE 10-20-8 manufactured by D.o. Weaver And Company.
[2687352]
Patient had an ambulatory eeg test done. A week after test, patient reported hair loss in spots where electrodes were attached. Patient reportedly in fairly good health, and no other products reported in her hair such as hair spray or perm.
Patient Sequence No: 1, Text Type: D, B5
[9822008]
Based on the nature of the complaint and the products involved, it is more likely that ten20 conductive paste was the cause of the hair loss, as opposed to nuprep skin prep gel. However, lamictal has also been known to cause hair loss in some patients. Multiple follow-up attempts made to assess the current condition of the patient, however, contact could never be established with the reporter. If we receive additional relevant information to this case, we will submit a follow-up report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1718791-2012-00006 |
| MDR Report Key | 2549607 |
| Report Source | 05 |
| Date Received | 2012-04-18 |
| Date of Report | 2012-04-16 |
| Date of Event | 2012-03-12 |
| Date Mfgr Received | 2012-03-19 |
| Device Manufacturer Date | 2011-09-01 |
| Date Added to Maude | 2012-04-27 |
| 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 | ELECTROCONDUCTIVE MEDIA (CODE: GYB) |
| Product Code | GYB |
| Date Received | 2012-04-18 |
| Model Number | 10-20-8 |
| Catalog Number | 10-20-8 |
| Lot Number | 165 |
| Device Expiration Date | 2014-09-30 |
| 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 | AURORA CO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-04-18 |