Brand Name | HEMCSM10 |
Type of Device | HEMOSPHERE CLEARSIGHT MODULE |
Manufacturer (Section D) |
EDWARDS LIFESCIENCES |
one edwards way |
irvine CA 92614 |
|
Manufacturer (Section G) |
EDWARDS LIFESCIENCES |
one edwards way |
|
irvine CA 92614 |
|
Manufacturer Contact |
katheryn
cespedes
|
one edwards way |
irvine, CA 92614
|
|
MDR Report Key | 19043636 |
MDR Text Key | 339484196 |
Report Number | 2015691-2024-02574 |
Device Sequence Number | 1 |
Product Code |
DQK
|
UDI-Device Identifier | 00690103202762 |
UDI-Public | (01)00690103202762(11)210612 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K203687 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Consumer,Health Professional,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
05/16/2024 |
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 | HEMCSM10 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
03/15/2024
|
Initial Date FDA Received | 04/04/2024 |
Supplement Dates Manufacturer Received | 05/01/2024
|
Supplement Dates FDA Received | 05/16/2024
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 06/12/2021 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |