Brand Name | TRANS-RAY PLUS 7.5 FR. 35CC 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 |
dorota
wolpiuk
|
15 law drive |
fairfield, NJ 07004
|
|
MDR Report Key | 10711603 |
MDR Text Key | 212312839 |
Report Number | 2248146-2020-00553 |
Device Sequence Number | 1 |
Product Code |
DSP
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
10/21/2020 |
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 |
Health Professional
|
Device Expiration Date | 11/18/2022 |
Device Catalogue Number | 0684-00-0604 |
Device Lot Number | 3000109191 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/30/2020 |
Initial Date FDA Received | 10/21/2020 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 11/18/2019 |
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 |