Brand Name | Cook Spectrum |
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 Contact |
larry
pool
|
750 daniels way |
bloomington, IN 47404
|
8128294891
|
|
MDR Report Key | 6877517 |
MDR Text Key | 87744745 |
Report Number | 1820334-2017-03123 |
Device Sequence Number | 1 |
Product Code |
FOZ
|
UDI-Device Identifier | 00827002535992 |
UDI-Public | (01)00827002535992(17)171101(10)5523693 |
Combination Product (y/n) | N |
Reporter Country Code | IN |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
09/19/2017 |
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 | G53599 |
Device Catalogue Number | C-UTLM-701J-ABRM-HC-RD-P |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/12/2017 |
Initial Date FDA Received | 09/19/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/18/2014 |
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 | 69 YR |
|
|