Brand Name | GUNTHER TULIP |
Type of Device | FILTER, INTRAVASCULAR, CARDIOVASCULAR |
Manufacturer (Section D) |
COOK, INC. |
750 daniels way |
bloomington IN 47402 |
|
MDR Report Key | 5331567 |
MDR Text Key | 34536637 |
Report Number | 5331567 |
Device Sequence Number | 1 |
Product Code |
DTK
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
12/28/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/29/2015 |
Is this an Adverse Event Report? |
Yes
|
Device Operator |
Physician
|
Device Expiration Date | 01/31/2018 |
Device Model Number | G33016 |
Device Catalogue Number | IGTCFS-65-FEM |
Other Device ID Number | 5642231 |
Was Device Available for Evaluation? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 12/28/2015 |
Device Age | 1 DY |
Event Location |
Hospital
|
Date Report to Manufacturer | 12/28/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 58 YR |
|
|