Brand Name | FLIXENE VASCULAR GRAFT |
Type of Device | PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER |
Manufacturer (Section D) |
ATRIUM MEDICAL CORPORATION |
40 continental blvd |
merrimack NH 03054 |
|
MDR Report Key | 10170133 |
MDR Text Key | 196217257 |
Report Number | 3011175548-2020-00828 |
Device Sequence Number | 1 |
Product Code |
DSY
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Type of Report
| Initial,Followup |
Report Date |
06/18/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/18/2020 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 10/14/2020 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|