MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2014-09-24 for TEN20 CONDUCTIVE PASTE 10-20-XX manufactured by D. O. Weaver And Company.
[18921425]
Received copy of medwatch form from fda on (b)(6) 2014; form was a copy of a user-facility submission regarding an injury from our products, nuprep skin prep gel and ten20 conductive paste. Patient had an eeg in which both of our products were used. The eeg leads remained on the patient overnight. When the leads were removed the day following the eeg, two (2) pink areas on the skin of the forehead were observed. About an hour later, the pink areas increased in size and intensity, especially the area on the right side, which was edematous and slightly abraded to the center. The areas continued to increase in size and became more irritated over the next hour. Doctors were alerted and the skin team was consulted.
Patient Sequence No: 1, Text Type: D, B5
[19095122]
Initial reported contacted to ascertain the current status of the patient, such as if the patient ended up suffering permanent scarring or if the patient recovered completely. As of (b)(4)2014, no reply from the user facility. If we receive any additional information from the user facility, we will submit a follow-up report. We are aware that a very small percentage of the population may react negatively to our products, likely due to hypersensitive skin and/or allergies. It is very rare that permanent scarring results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1718791-2014-00004 |
| MDR Report Key | 4115949 |
| Report Source | 00 |
| Date Received | 2014-09-24 |
| Date of Report | 2014-09-19 |
| Date of Event | 2014-03-23 |
| Date Mfgr Received | 2014-08-25 |
| Date Added to Maude | 2014-09-25 |
| 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 | RISK MANAGER |
| 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 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 | TEN20 |
| Product Code | GYB |
| Date Received | 2014-09-24 |
| Model Number | 10-20-XX |
| Catalog Number | 10-20-XX |
| Lot Number | UNK |
| Operator | MEDICAL TECHNOLOGIST |
| 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 | 2014-09-24 |