Brand Name | SENSATION PLUS 8FR. 50CC IAB |
Type of Device | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL |
Manufacturer (Section D) |
DATASCOPE CORP. - FAIRFIELD |
15 law drive |
fairfield NJ 07004 |
|
Manufacturer (Section G) |
DATASCOPE CORP. - FAIRFIELD |
15 law drive |
|
fairfield NJ 07004 |
|
Manufacturer Contact |
|
15 law drive |
fairfield, NJ 07004
|
|
MDR Report Key | 8522640 |
MDR Text Key | 142522447 |
Report Number | 2248146-2019-00298 |
Device Sequence Number | 1 |
Product Code |
DSP
|
Combination Product (y/n) | N |
PMA/PMN Number | K112327 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
|
Type of Report
| Initial,Followup,Followup |
Report Date |
06/12/2019 |
1 Device was Involved in the Event |
|
0 Patients were Involved in the Event: |
|
Date FDA Received | 04/17/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
|
Device Expiration Date | 10/10/2021 |
Device Catalogue Number | 0684-00-0575 |
Device Lot Number | 3000081750 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/15/2019 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
|
Device Age | YR |
Event Location |
No Information
|
Date Manufacturer Received | 06/10/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/10/2018 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
|