MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-06-08 for NICOLET VIKING EDX 982A0589 manufactured by Natus Neurology Incorporated.
[16993763]
A customer called to inform natus neurology that an injury occurred while using the nicolet viking edx. A pt was burned at the needle electrode site when the doctor was conducting a stimulated single fiber emg.
Patient Sequence No: 1, Text Type: D, B5
[17271522]
Registered internally as a complaint (b)(4) for further investigation by manufacturer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010611950-2015-00002 |
| MDR Report Key | 4826455 |
| Report Source | 05 |
| Date Received | 2015-06-08 |
| Date of Report | 2015-05-14 |
| Date of Event | 2015-05-14 |
| Date Mfgr Received | 2015-05-14 |
| Device Manufacturer Date | 2014-06-01 |
| Date Added to Maude | 2015-06-10 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | TONI GORMAN |
| Manufacturer Street | 3150 PLEASANT VIEW ROAD |
| Manufacturer City | MIDDLETON WI 53562 |
| Manufacturer Country | US |
| Manufacturer Postal | 53562 |
| Manufacturer Phone | 6088298600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NICOLET VIKING EDX |
| Generic Name | VIKING EDX |
| Product Code | IKN |
| Date Received | 2015-06-08 |
| Returned To Mfg | 2015-05-22 |
| Model Number | 982A0589 |
| Catalog Number | 982A0589 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS NEUROLOGY INCORPORATED |
| Manufacturer Address | 3150 PLEASANT VIEW ROAD MIDDLETON WI 53562 US 53562 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-06-08 |