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 | 18852040 |
MDR Text Key | 337070682 |
Report Number | 1820334-2024-00299 |
Device Sequence Number | 1 |
Product Code |
FOZ
|
UDI-Device Identifier | 00827002440159 |
UDI-Public | (01)00827002440159(17)250131(10)15580578 |
Combination Product (y/n) | Y |
Reporter Country Code | US |
PMA/PMN Number | K033843 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
03/06/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/06/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | N/A |
Device Catalogue Number | C-UTLMY-501J-RSC-ABRM-HC-FST |
Device Lot Number | 15580578 |
Was Device Available for Evaluation? |
Yes
|
Date Manufacturer Received | 02/26/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/26/2023 |
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 |