Brand Name | HERO SUPER HERO |
Type of Device | VASCULAR GRAFT |
Manufacturer (Section D) |
MERIT MEDICAL SYSTEMS, INC. |
1600 merit parkway |
south jordan UT 94095 |
|
Manufacturer (Section G) |
MERIT MEDICAL SYSTEMS, INC. |
1600 merit parkway |
|
south jordan UT 94095 |
|
Manufacturer Contact |
casey
hughes, ms, cqe, csqp
|
1600 merit parkway |
south jordan, UT 94095
|
8012531600
|
|
MDR Report Key | 6835721 |
MDR Text Key | 84269709 |
Report Number | 1721504-2017-00164 |
Device Sequence Number | 1 |
Product Code |
DSY
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | K124039 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
08/10/2017 |
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 |
Physician
|
Device Expiration Date | 04/30/2018 |
Device Catalogue Number | HERO1000 |
Device Lot Number | H1028856 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 08/31/2017 |
Supplement Dates Manufacturer Received | 09/08/2017
|
Supplement Dates FDA Received | 09/14/2017
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/19/2016 |
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 |
Patient Outcome(s) |
Life Threatening;
Required Intervention;
|
|
|