Brand Name | GUNTHER TULIP NAVALIGN JUGULAR & FEMORAL 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 | 6299349 |
MDR Text Key | 66565263 |
Report Number | 3002808486-2017-00215 |
Device Sequence Number | 1 |
Product Code |
DTK
|
UDI-Device Identifier | 10827002529264 |
UDI-Public | (01)10827002529264(17)160612(10)E3099157 |
Combination Product (y/n) | N |
Reporter Country Code | UK |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,o |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
09/05/2013 |
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 Catalogue Number | IGTCFS-65-2-UNI-TULIP |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/05/2013 |
Initial Date FDA Received | 02/03/2017 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 06/12/2013 |
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 Outcome(s) |
Required Intervention;
|