Brand Name | ANTEGRADE CARDIOPLEGIA CANNULA |
Type of Device | CANNULA |
Manufacturer (Section D) |
SURGE CARDIOVASCULAR |
2680 walker ave nw, suite c |
walker MI 49544 |
|
Manufacturer (Section G) |
SURGE CARDIOVASCULAR |
2680 walker ave nw, suite c |
|
walker MI 49544 |
|
Manufacturer Contact |
kelli
jonas
|
2680 walker ave nw, suite c |
walker, MI 49544
|
6168869463
|
|
MDR Report Key | 7516414 |
MDR Text Key | 108752860 |
Report Number | 3004986960-2018-00001 |
Device Sequence Number | 1 |
Product Code |
DWF
|
Combination Product (y/n) | N |
PMA/PMN Number | K964198 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Type of Report
| Initial |
Report Date |
05/15/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 11/01/2021 |
Device Catalogue Number | ANT-1014S |
Device Lot Number | 00559-110617 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/02/2018 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
04/24/2018 |
Initial Date FDA Received | 05/15/2018 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/06/2017 |
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 |
|
|