MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2014-06-06 for TEN20 CONDUCTIVE PASTE 10-20-XX manufactured by D.o. Weaver And Company.
[4571995]
User facility recently used nuprep skin prep gel and ten20 conductive paste together with a non-invasive electric current stimulation device (tdcs plus, neuroconn, (b)(6)) and encountered the following incident: a patient lost all hair on the spots where the dcs electrodes were positioned. In order to induce right hemispheric fronto-cortical dominance, the anode was positioned over right inferior frontal cortex (f8), while the cathode was positioned over left inferior frontal cortex (f7). Direct current was induced using a dc-stimulator plus and 5x7cm standard electrodes (neuroconn, (b)(6)). Electrodes were fixated using conductive eeg gel (ten20 conductive neurodiagnostic electrode paste, weaver and (b)(4)). A 1. 5ma direct current were induced for a duration of 1500s, including ramping up and down phases of 20s each.
Patient Sequence No: 1, Text Type: D, B5
[12128871]
User facility remained in contact with patient after the incident to determine the status of the hair loss. On (b)(6) 2014, patient told user facility that all of the hair that was lost is beginning to regrow. Patient also emphasized that he believes his hair loss was not caused by the procedure or our products. Patient is expected to recover completely.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1718791-2014-00001 |
| MDR Report Key | 3939196 |
| Report Source | 01,06 |
| Date Received | 2014-06-06 |
| Date of Report | 2014-05-30 |
| Date of Event | 2014-04-01 |
| Date Mfgr Received | 2014-05-06 |
| Date Added to Maude | 2014-07-18 |
| 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 | MR. NICHOLAS LEE |
| Manufacturer Street | 565 NUCLA WAY, UNIT B |
| Manufacturer City | AURORA CO 80011 |
| Manufacturer Country | US |
| Manufacturer Postal | 80011 |
| Manufacturer Phone | 3033661804 |
| Manufacturer G1 | D.O. WEAVER CO. |
| Manufacturer Street | 565 NUCLA WAY, UNIT B |
| Manufacturer City | AURORA CO 80011 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80011 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TEN20 CONDUCTIVE PASTE |
| Generic Name | ELECTRODE CONDUCTIVE PASTE |
| Product Code | GYB |
| Date Received | 2014-06-06 |
| Model Number | 10-20-XX |
| Catalog Number | 10-20-XX |
| Lot Number | UNK |
| Operator | OTHER |
| 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 | 565-B NUCLA WAY UNIT B AURORA CO 80011 US 80011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-06-06 |