Brand Name | EVD/CSF |
Type of Device | EDS 3 DRAINAGE SYSTEM |
Manufacturer (Section D) |
NATUS NEURO INCORPORATED |
5955 pacific center boulevard |
san diego CA 92121 |
|
Manufacturer (Section G) |
NATUS NEUROLOGY INCORPORATED |
5955 pacific center boulevard |
|
san diego CA 92121 |
|
Manufacturer Contact |
janessa
boone
|
3150 pleasant view road |
middleton, WI 53562
|
6088298603
|
|
MDR Report Key | 9187785 |
MDR Text Key | 166127867 |
Report Number | 3010611950-2019-00057 |
Device Sequence Number | 1 |
Product Code |
JXG
|
Combination Product (y/n) | N |
PMA/PMN Number | K061568 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
user facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
09/20/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 821731 |
Device Catalogue Number | 821731 |
Device Lot Number | 3490942 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/20/2019 |
Initial Date FDA Received | 10/14/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|