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 | 19144988 |
MDR Text Key | 341134888 |
Report Number | 1820334-2024-00553 |
Device Sequence Number | 1 |
Product Code |
FOZ
|
UDI-Device Identifier | 00827002478299 |
UDI-Public | (01)00827002478299(17)260103(10)15469165 |
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,Distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
04/19/2024 |
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 | N/A |
Device Catalogue Number | C-UTLM-701J-RSC-ABRM-HC-RD |
Device Lot Number | 15469165 |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 04/19/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/31/2023 |
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 |
Patient Age | 55 YR |
Patient Sex | Male |
Patient Weight | 76 KG |