Brand Name | PERCEVAL SUTURELESS AORTIC HEART VALVE |
Type of Device | TISSUE HEART VALVE |
Manufacturer (Section D) |
CORCYM CANADA CORP. |
5005 north fraser way |
burnaby, bc V5J 5 M1 |
CA V5J 5M1 |
|
MDR Report Key | 13023355 |
MDR Text Key | 285338382 |
Report Number | 3019892983-2021-01048 |
Device Sequence Number | 1 |
Product Code |
LWR
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
11/17/2021,12/16/2021 |
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 |
Health Professional
|
Device Model Number | TBD |
Device Catalogue Number | TBD |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 11/17/2021 |
Event Location |
Hospital
|
Date Report to Manufacturer | 11/17/2021 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 12/16/2021 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|