Brand Name | COAGUCHEK XS PT TEST |
Type of Device | TEST, TIME, PROTHROMBIN |
Manufacturer (Section D) |
|
MDR Report Key | 8089826 |
MDR Text Key | 128191662 |
Report Number | MW5081479 |
Device Sequence Number | 1 |
Product Code |
GJS
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Unknown
|
Type of Report
| Initial |
Report Date |
11/17/2018 |
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? |
No
|
Device Operator |
No Information
|
Device Catalogue Number | 04625374160 |
Device Lot Number | 29778721 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 11/19/2018 |
Was Device Evaluated by Manufacturer? |
No Information
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 57 YR |
Patient Weight | 92 |
|
|