Brand Name | HERO ARTERIAL GRAFT COMPONENT |
Type of Device | HERO ARTERIAL GRAFT COMPONENT |
Manufacturer (Section D) |
MERIT MEDICAL SYSTEMS INC. |
1600 merit parkway |
south jordan UT 84095 |
|
Manufacturer (Section G) |
MERIT MEDICAL SYSTEMS INC. |
1600 merit parkway |
|
south jordan UT 84095 |
|
Manufacturer Contact |
casey
hughes ms, cqe.
|
merit medical systems inc |
1600 merit parkway |
south jordan, UT 84095
|
8013164932
|
|
MDR Report Key | 6063471 |
MDR Text Key | 58716895 |
Report Number | 1721504-2016-00199 |
Device Sequence Number | 1 |
Product Code |
DSY
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K124039 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup |
Report Date |
10/06/2016 |
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 |
Physician
|
Device Expiration Date | 04/30/2017 |
Device Catalogue Number | HERO1002 |
Device Lot Number | H15AV011 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/17/2016 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/06/2016 |
Initial Date FDA Received | 10/28/2016 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 11/03/2016
|
Was Device Evaluated by Manufacturer? |
Yes
|
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 |