Type of Device | SIZER, HEART-VALVE, PROSTHESIS |
Manufacturer (Section D) |
EDWARDS LIFESCIENCES |
one edwards way |
irvine CA 92614 |
|
Manufacturer (Section G) |
EDWARDS LIFESCIENCES LLC |
one edwards way |
|
irvine CA 92614 |
|
Manufacturer Contact |
neil
landry
|
one edwards way |
ms: lfs 33 |
irvine, CA 92614
|
9492502289
|
|
MDR Report Key | 4842117 |
MDR Text Key | 6193478 |
Report Number | 2015691-2015-01390 |
Device Sequence Number | 1 |
Product Code |
DTI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility |
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial,Followup |
Report Date |
05/15/2015 |
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 | 1133 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
05/15/2015 |
Initial Date FDA Received | 06/12/2015 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 07/27/2015
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|