Brand Name | SENSATION PLUS 8FR. 50CC IAB WITH ACCESSORIES, US ONLY |
Type of Device | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL |
Manufacturer (Section D) |
DATASCOPE CORP. |
15 law drive |
fairfield NJ 07004 |
|
MDR Report Key | 10991473 |
MDR Text Key | 220921548 |
Report Number | 10991473 |
Device Sequence Number | 1 |
Product Code |
DSP
|
UDI-Device Identifier | 10607567109633 |
UDI-Public | (01)10607567109633 |
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
11/18/2020,11/17/2020 |
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 |
No Information
|
Device Model Number | 0684-00-0576-01U |
Device Catalogue Number | 0684-00-0576-01U |
Device Lot Number | 3000128425 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 11/18/2020 |
Date Report to Manufacturer | 12/11/2020 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 12/11/2020 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|