Brand Name | SWAN-GANZ CONTROLCATH |
Type of Device | CATHETER, INTRAVASCULAR, DIAGNOSTIC |
Manufacturer (Section D) |
EDWARDS LIFESCIENCES LLC |
one edwards way |
irvine CA 92614 |
|
MDR Report Key | 8189238 |
MDR Text Key | 131166882 |
Report Number | 8189238 |
Device Sequence Number | 1 |
Product Code |
DQO
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
12/12/2018,12/06/2018 |
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 Model Number | C146F7 |
Device Catalogue Number | C146F7 |
Device Lot Number | 61508122 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 12/12/2018 |
Device Age | 1 MO |
Event Location |
Hospital
|
Date Report to Manufacturer | 12/21/2018 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 12/21/2018 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 20805 DA |
|
|