Brand Name | SWAN-GANZ |
Type of Device | SWAN GANZ CATHETER |
Manufacturer (Section D) |
EDWARDS LIFESCIENCES, LLC. |
one edwards way |
irvine CA 92614 |
|
MDR Report Key | 5100055 |
MDR Text Key | 26650415 |
Report Number | 5100055 |
Device Sequence Number | 1 |
Product Code |
DYG
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Other
|
Report Date |
09/18/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Physician
|
Device Expiration Date | 08/04/2016 |
Device Catalogue Number | 7466HF8 |
Device Lot Number | 59967285 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 09/18/2015 |
Event Location |
Hospital
|
Date Report to Manufacturer | 09/18/2015 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 09/24/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 54 YR |
Patient Weight | 87 |
|
|