Brand Name | SENSATION 7FR. 40CC IAB |
Type of Device | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL |
Manufacturer (Section D) |
DATASCOPE FAIRFIELD |
15 law drive |
fairfield NJ 07004 |
|
Manufacturer (Section G) |
DATASCOPE FAIRFIELD |
15 law drive |
|
fairfield NJ 07004 |
|
Manufacturer Contact |
|
15 law drive |
fairfield, NJ 07004
|
|
MDR Report Key | 8182884 |
MDR Text Key | 131012915 |
Report Number | 2248146-2018-00734 |
Device Sequence Number | 1 |
Product Code |
DSP
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K063525 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
12/19/2018 |
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 Expiration Date | 05/24/2021 |
Device Catalogue Number | 0684-00-0434 |
Device Lot Number | 3000074101 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/30/2018 |
Initial Date FDA Received | 12/19/2018 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 05/24/2018 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |