Type of Device | FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS |
Manufacturer (Section D) |
COOK INC |
750 daniels way |
bloomington IN 47404 |
|
Manufacturer (Section G) |
COOK INC |
750 daniels way |
|
bloomington IN 47404 |
|
Manufacturer Contact |
jason
crouch
|
750 daniels way |
bloomington, IN 47404
|
8123392235
|
|
MDR Report Key | 11852212 |
MDR Text Key | 266890119 |
Report Number | 1820334-2021-01363 |
Device Sequence Number | 1 |
Product Code |
FOZ
|
UDI-Device Identifier | 00827002531833 |
UDI-Public | (01)00827002531833(17)220728(10)13333179 |
Combination Product (y/n) | Y |
PMA/PMN Number | K081113 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Health Professional,User Facility |
Reporter Occupation |
|
Type of Report
| Initial,Followup |
Report Date |
07/14/2022 |
1 Device was Involved in the Event |
|
0 Patients were Involved in the Event: |
|
Date FDA Received | 05/19/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
|
Device Expiration Date | 07/28/2022 |
Device Model Number | N/A |
Device Lot Number | 13333179 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 06/21/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/28/2020 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
|
|