MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-09-17 for DEVICE 1: TEN20 CONDUCTIVE PASTE 10-20-XX manufactured by D.o. Weaver Co..
[2895694]
Holter eeg administered to a (b)(6) female child, within the scope of nocturnal bed-wetting, with 8 39in/100cm gold cephalic electrodes on (b)(6) 2012. The same evening a tingling/burning sensation was felt by the pt. The electrodes were removed at midnight, at which time a wound 1. 5cm in diameter was discovered with burned hair at the site of the right parietal electrode. Medical consult on (b)(6) 2012: observation of a black patch, approx. 2 cm in diameter, rounded, forming a thick, black crust, with no sign of inflammation, not sensitive to the touch, and no sign of surrounding infection. No other lesions on the body or head noted. The placement of the electrodes was done by an experienced nurse, following usual protocol. Second medical consult on (b)(6) 2012: lesion had regressed to approx. 1. 5 cm in diameter.
Patient Sequence No: 1, Text Type: D, B5
[10179625]
Complaint received from (b)(6) authorized rep ((b)(4)). (b)(4) received the complaint from (b)(6). Pt was treated with the following measures: prescription of biafine on (b)(6) 2012; ialuset plus and vaseline on (b)(6) 2012. No further info from (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1718791-2012-00012 |
| MDR Report Key | 2752792 |
| Report Source | 05 |
| Date Received | 2012-09-17 |
| Date of Report | 2012-09-17 |
| Date of Event | 2012-05-16 |
| Date Mfgr Received | 2012-08-17 |
| Date Added to Maude | 2012-09-21 |
| 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 | DEVICE 1: TEN20 CONDUCTIVE PASTE |
| Generic Name | ELECTROCONDUCTIVE MEDIA (CODE: GYB) |
| Product Code | GYB |
| Date Received | 2012-09-17 |
| Model Number | 10-20-XX |
| Catalog Number | 10-20-XX |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | D.O. WEAVER CO. |
| Manufacturer Address | AURORA CO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-09-17 |