Brand Name | FUSION BIOLINE 8MM-40CM SUPP PERIPHERAL GRAFT |
Type of Device | VASXCULAR GRAFT |
Manufacturer (Section D) |
MAQUET CARDIOVASCULAR, LLC |
wayne NJ |
|
Manufacturer (Section G) |
MAQUET CARDIOVASCULAR, LLC |
45 barbour pond drive |
|
wayne NJ 07470 |
|
Manufacturer Contact |
tina
evancho
|
45 barbour pond drive |
wayne, NJ 07470
|
9737097265
|
|
MDR Report Key | 4759519 |
MDR Text Key | 19722493 |
Report Number | 2242352-2015-00378 |
Device Sequence Number | 1 |
Product Code |
DSY
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility,Company Representative,company represent |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
04/10/2015 |
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 Expiration Date | 03/31/2017 |
Device Model Number | M002015030480 |
Device Lot Number | 25095076 |
Was Device Available for Evaluation? |
Yes
|
Date Returned to Manufacturer | 04/17/2015 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/10/2015
|
Initial Date FDA Received | 05/06/2015 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 07/13/2015
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 04/01/2014 |
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 |
|
|