MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-02-12 for TEN20 CONDUCTIVE PASTE 10-20 manufactured by D. O. Weavere And Company.
[3641045]
Patient has a sleep study conducted during the night of (b)(6) 2013. Sleep technologists used nuprep skin prep gel to prep the skin in the areas where electrodes were to be placed. Technologists then placed electrodes at the prepped sites, using ten20 conductive paste as the medium to adhere the electrodes to the pt's scalp. Electrodes were kept on overnight, and removed the morning of (b)(6) 2013, around 5:30am. A few hours after the pt got home, she washed her hair. During the washing, she noticed that the hair at the electrode sites were falling out. The pt reported that hair continued falling out as she brushed her hair. Pt was referred to dermatologist for evaluation. Dermatologist reviewed pt's medical history and noted that the pt is on many medications, including toprol. Dermatologist also noted that toprol is unk to cause adverse reactions when topical solutions, like nuprop and ton20, are used in sleep studies. Dermatologist prescribed by hydrocortizone cream for the electrode sites, as well as some shampoo to relieve irritation.
Patient Sequence No: 1, Text Type: D, B5
[10985819]
Followed up with pt on (b)(6) 2013. Pt stated that she feels much better and that all the itching, irritation, and redness that accompanied the hair loss have subsided. Pt stated no additional follow-up would be necessary.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1718791-2013-00002 |
| MDR Report Key | 3262801 |
| Report Source | 06 |
| Date Received | 2013-02-12 |
| Date of Report | 2013-02-12 |
| Date of Event | 2013-02-08 |
| Date Mfgr Received | 2013-02-08 |
| Date Added to Maude | 2013-08-06 |
| 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 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 CONDUCTIVE PASTE |
| Product Code | GYB |
| Date Received | 2013-02-12 |
| Model Number | 10-20 |
| Catalog Number | 10-20 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | D. O. WEAVERE AND COMPANY |
| Manufacturer Address | 565 NUCLA WAY UNIT B AURORA CO 80011 US 80011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-02-12 |