Brand Name | FEMORAL ARTERY PRESSURE MONITORING SET |
Type of Device | DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC |
Manufacturer (Section D) |
COOK INC |
750 daniels way |
bloomington IN 47404 |
|
Manufacturer (Section G) |
COOK INC |
750 daniels way |
|
bloomington IN 47404 |
|
Manufacturer Contact |
larry
pool
|
750 daniels way |
bloomington, IN 47404
|
8128294891
|
|
MDR Report Key | 8171852 |
MDR Text Key | 130787469 |
Report Number | 1820334-2018-03831 |
Device Sequence Number | 1 |
Product Code |
DQO
|
UDI-Device Identifier | 00827002019096 |
UDI-Public | (01)00827002019096(17)171217(10)5523707 |
Combination Product (y/n) | N |
Reporter Country Code | BR |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign,other |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
12/17/2018 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 12/17/2017 |
Device Catalogue Number | C-PMS-400-FA |
Device Lot Number | 5523707 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
12/14/2018
|
Initial Date FDA Received | 12/17/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/17/2014 |
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 Age | 67 YR |