MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-02-23 for TEN20 CONDUCTIVE PASTE 10-20-XX manufactured by D. O. Weaver And Company.
[68141350]
Attempted follow-up with patient multiple times, but no response. It is a known fact that a very small percentage of the population will react negatively to topical products. Based on the information provided, patient may have experienced an allergic reaction to nuprep and/or ten20. Without further information, we cannot determine a more definitive cause. If additional information becomes available, we will file a follow-up report. Device not available to patient.
Patient Sequence No: 1, Text Type: N, H10
[68141351]
Pt had sleep study at (b)(6). Pt experienced burning sensations and itching where the electrodes were attached on her head. She awoke at 3:30 am and asked for help, but the medical technologist would not let her use a shower to rinse her hair. She left the hospital and went home to wash her hair. She then discovered burn-like spots and missing hair where the electrodes were placed. She saw a dermatologist, who told her that she had "3rd degree action" to gel/paste. Dermatologist gave her cream to put on scabs and medicated shampoo, and advised her not to use any other hair products until she was completely healed. Pt said she advised the tech that she had very sensitive skin and was sensitive to tape adhesive. Tech told her the tape was non-sensitive and that she would not have any problems with the tape. Pt not completely sure what products were used during the sleep study, but might have been nuprep and/or ten20.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1718791-2017-00003 |
| MDR Report Key | 6353027 |
| Report Source | CONSUMER |
| Date Received | 2017-02-23 |
| Date of Report | 2017-02-23 |
| Date of Event | 2017-01-19 |
| Date Mfgr Received | 2017-01-23 |
| Date Added to Maude | 2017-02-23 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | 2017-02-23 |
| Model Number | 10-20-XX |
| Catalog Number | 10-20-XX |
| 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 | 2017-02-23 |