Brand Name | SENSATION 7FR. 40CC IAB |
Type of Device | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL |
Manufacturer (Section D) |
DATASCOPE CORP. - FAIRFIELD |
15 law drive |
fairfield NJ |
|
Manufacturer (Section G) |
DATASCOPE CORP. - FAIRFIELD |
15 law drive |
|
fairfield NJ |
|
Manufacturer Contact |
brian
schaeffer
|
15 law drive |
fairfield, NJ
|
|
MDR Report Key | 13876184 |
MDR Text Key | 287770843 |
Report Number | 2248146-2022-00234 |
Device Sequence Number | 1 |
Product Code |
DSP
|
Combination Product (y/n) | N |
Reporter Country Code | BE |
PMA/PMN Number | K063525 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility,Company Representative |
Reporter Occupation |
Pharmacist
|
Type of Report
| Initial,Followup,Followup,Followup |
Report Date |
06/02/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/24/2022 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
|
Device Model Number | 0684-00-0470-01 |
Device Catalogue Number | 0684-00-0434 |
Device Lot Number | 3000136078 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 06/02/2022 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/04/2020 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
|
Patient Treatment Data |
Date Received: 03/24/2022 Patient Sequence Number: 1 |
|
|