Brand Name | SWAN-GANZ CCOMBO 8FR |
Type of Device | CATHETER, FLOW DIRECTED |
Manufacturer (Section D) |
EDWARDS LIFESCIENCES LLC |
one edwards way |
irvine CA 92614 |
|
MDR Report Key | 16145551 |
MDR Text Key | 307162884 |
Report Number | 16145551 |
Device Sequence Number | 1 |
Product Code |
DYG
|
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 |
01/03/2023,12/13/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/12/2023 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 777F8 |
Device Catalogue Number | 777F8 |
Device Lot Number | 64470783 |
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 | 01/03/2023 |
Date Report to Manufacturer | 01/12/2023 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Age | 23360 DA |
Patient Sex | Female |
|
|