Brand Name | NEPTUNE 2 ROVER ULTRA (230V) |
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 | 8111782 |
MDR Text Key | 128749378 |
Report Number | 0001811755-2018-02572 |
Device Sequence Number | 1 |
Product Code |
JCX
|
UDI-Device Identifier | 07613154559046 |
UDI-Public | 07613154559046 |
Combination Product (y/n) | N |
Reporter Country Code | GB |
PMA/PMN Number | K132671 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Nurse
|
Type of Report
| Initial,Followup |
Report Date |
08/01/2019 |
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 | 0702002000 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/06/2018 |
Initial Date FDA Received | 11/28/2018 |
Supplement Dates Manufacturer Received | 08/01/2019
|
Supplement Dates FDA Received | 08/01/2019
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 08/09/2017 |
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 |
|
|