Brand Name | COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET |
Type of Device | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR |
Manufacturer (Section D) |
WILLIAM COOK EUROPE |
4632 bjaeverskov |
|
DA |
|
Manufacturer Contact |
marianne
hoey
|
sandet 6 |
bjaeverskov 4632
|
DA
4632
|
56868686
|
|
MDR Report Key | 5895792 |
MDR Text Key | 52722857 |
Report Number | 3002808486-2016-00874 |
Device Sequence Number | 1 |
Product Code |
DTK
|
UDI-Device Identifier | 10827002345048 |
UDI-Public | (01)10827002345048(17)180608(10)E3336121 |
Combination Product (y/n) | N |
Reporter Country Code | GB |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
11/30/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/23/2016 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | IGTCFS-65-2-UNI-CELECT-PT |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 11/30/2015 |
Date Device Manufactured | 06/08/2015 |
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 |