D
Patient 1
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.
MAUDE MDR 4826455
- MDR report key
- 4826455
- Report number
- 3010611950-2015-00002
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-05-14
- Date received
- 2015-06-08
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 401
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- TONI GORMAN
- Address
- 3150 PLEASANT VIEW ROAD MIDDLETON WI 53562 US
- Phone
- 608-608-6088
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NICOLET VIKING EDX | VIKING EDX | NATUS NEUROLOGY INCORPORATED | IKN | 982A0589 | 982A0589 | NA | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-06-08 | 0 | 1. R |
Event Narratives#
N
Patient 1
REGISTERED INTERNALLY AS A COMPLAINT (B)(4) FOR FURTHER INVESTIGATION BY MANUFACTURER.