Brand Name | MERIT CUSTOM KIT |
Type of Device | CUSTOM KIT |
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 |
katie
swenson cqe, cba, cqpa
|
1600 merit parkway |
south jordan, UT 84095
|
|
MDR Report Key | 7470693 |
MDR Text Key | 106849213 |
Report Number | 1721504-2018-00038 |
Device Sequence Number | 1 |
Product Code |
DQO
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,distri |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
03/29/2018 |
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 |
No Information
|
Device Expiration Date | 02/28/2021 |
Device Catalogue Number | K12-MZT3100D |
Device Lot Number | H1294588 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/14/2018 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
03/29/2018 |
Initial Date FDA Received | 04/27/2018 |
Supplement Dates Manufacturer Received | 05/17/2018
|
Supplement Dates FDA Received | 05/25/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/14/2018 |
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 |
|
|