Brand Name | GUARDIAN II |
Type of Device | HEMOSTASIS VALVE |
Manufacturer (Section D) |
VASCULAR SOLUTIONS, INC. |
6464 sycamore court north |
maple grove MN 55369 |
|
Manufacturer (Section G) |
VASCULAR SOLUTIONS, INC. |
6464 sycamore court north |
|
minneapolis MN 55369 |
|
Manufacturer Contact |
renee
michael
|
6464 sycamore court north |
maple grove, MN 55369
|
7636564366
|
|
MDR Report Key | 5510406 |
MDR Text Key | 40668399 |
Report Number | 2134812-2016-00017 |
Device Sequence Number | 1 |
Product Code |
DTL
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K122301 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,user f |
Reporter Occupation |
Other
|
Remedial Action |
Recall |
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 | 03/18/2016 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Physician
|
Device Expiration Date | 09/30/2018 |
Device Model Number | 8210 |
Device Lot Number | 42108 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/31/2015 |
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 12/28/2015 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/13/2015 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
N
|
Removal/Correction Number | 2134812-03/16/2016-001R |
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|