Brand Name | NOVA STAT PROFILE CRITICAL CARE XPRESS |
Type of Device | CLINICAL CHEMISTRY CREATININE TEST SYSTEM |
Manufacturer (Section D) |
NOVA BIOMEDICAL CORPORATION |
200 prospect street |
waltham MA 02453 3465 |
|
Manufacturer (Section G) |
NOVA BIOMEDICAL CORP. |
200 prospect st |
|
waltham MA 02453 |
|
Manufacturer Contact |
taylor
ward
|
200 prospect st |
waltham, MA 02453
|
7816473700
|
|
MDR Report Key | 7694958 |
MDR Text Key | 114677454 |
Report Number | 1219029-2018-00001 |
Device Sequence Number | 1 |
Product Code |
CGL
|
UDI-Device Identifier | 00385480359429 |
UDI-Public | 00385480359429 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K20297 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
07/11/2018 |
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 Model Number | 35942 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
07/11/2018 |
Initial Date FDA Received | 07/17/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |
Patient Outcome(s) |
Other;
|