Brand Name | NEPTUNE 2 ROVER ULTRA (120V) |
Type of Device | APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED |
Manufacturer (Section D) |
STRYKER INSTRUMENTS-KALAMAZOO |
4100 east milham avenue |
kalamazoo MI 49001 |
|
Manufacturer (Section G) |
STRYKER INSTRUMENTS-KALAMAZOO |
4100 east milham avenue |
|
kalamazoo MI 49001 |
|
Manufacturer Contact |
zach
baker
|
4100 east milham avenue |
kalamazoo, MI 49001
|
2693237700
|
|
MDR Report Key | 7710356 |
MDR Text Key | 114708115 |
Report Number | 0001811755-2018-01182 |
Device Sequence Number | 1 |
Product Code |
JCX
|
UDI-Device Identifier | 07613154522309 |
UDI-Public | 07613154522309 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K132671 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
user facility |
Reporter Occupation |
Physician Assistant
|
Type of Report
| Initial |
Report Date |
07/23/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 0702001000 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
06/27/2018 |
Initial Date FDA Received | 07/23/2018 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 07/14/2011 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|