MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-05-24 for TEN20 CONDUCTIVE PASTE 10-20-XX manufactured by D.o. Weaver And Company.
[2791164]
Female pt underwent nerve conduction study at unreported clinic. Pt reported pulsing sensations after the study was complete.
Patient Sequence No: 1, Text Type: D, B5
[9929910]
Pt convinced exam did neurological damage to her system. Pt complains to have tingling sensation in her fingers at times, "pulsing sensation" in her thumb, and tingling sensations in her face. Doctor substituted ten20 paste for the ultrasound gel that is normally used for the procedure. Ten20 is labeled as "not recommended for use in current-inducing electrodes".
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1718791-2012-00011 |
| MDR Report Key | 2593032 |
| Report Source | 04 |
| Date Received | 2012-05-24 |
| Date of Report | 2012-05-23 |
| Date of Event | 2012-04-03 |
| Date Mfgr Received | 2012-05-09 |
| Date Added to Maude | 2012-06-04 |
| 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 | 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 | TEN20 CONDUCTIVE PASTE |
| Generic Name | ELECTROCONDUCTIVE MEDIA (CODE: GYB)` |
| Product Code | GYB |
| Date Received | 2012-05-24 |
| Model Number | 10-20-XX |
| Catalog Number | 10-20-XX |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | D.O. WEAVER AND COMPANY |
| Manufacturer Address | AURORA CO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-05-24 |