MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-08-23 for TEN20 CONDUCTIVE PASTE 10-20-XX manufactured by D. O. Weaver And Company.
[52761030]
Reference sus voluntary event report number mw5062558. Narrative on the report initially reported skin irritation at electrode sites of "several" patients. Additional information from the report mentioned the customer preference issue related to the change in manufacturing process of the calcium carbonate supplied to weaver and company. The product they are referring to (lots 184 to 274) met all performance requirements and specifications, but we know from customer feedback that clinical performance varied from our standard. Skin reaction occurs in a very small populations of patients who have sensitive skin. Also, long-term monitoring procedures have been shown to cause skin irritation in some patients. According to the ten20 ifu, the user is cautioned to be aware and monitor poor skin tolerance to topical applications, like ten20. See ten20 ifu caution statements. We find no evidence that a change in performance from the different calcium carbonate (lots 184 to 274) have caused any change in basic performance that has resulted in skin irritation. Device not available for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[52761031]
Received sus voluntary event report from fda on 8-11-2016. Initial reporter claimed they had several patients with continuous eeg monitoring who experienced skin irritation at the electrode sites after the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1718791-2016-00001 |
| MDR Report Key | 5896479 |
| Report Source | OTHER |
| Date Received | 2016-08-23 |
| Date of Report | 2016-08-16 |
| Date of Event | 2016-03-03 |
| Date Mfgr Received | 2016-08-11 |
| Date Added to Maude | 2016-08-23 |
| 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 | 3 |
| Event Location | 3 |
| 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 AND COMPANY |
| 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 | NEURODIAGNOSTIC ELECTRODE PASTE |
| Product Code | GYB |
| Date Received | 2016-08-23 |
| Model Number | 10-20-XX |
| Operator | NURSE |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | D. O. WEAVER AND COMPANY |
| Manufacturer Address | 565 NUCLA WAY, UNIT B AURORA CO 80011 US 80011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-08-23 |