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
|
8012531600
|
|
MDR Report Key | 7625213 |
MDR Text Key | 111891729 |
Report Number | 1721504-2018-00288 |
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 |
05/24/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/21/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Expiration Date | 11/21/2017 |
Device Model Number | H1242233 |
Device Catalogue Number | K04-MZL6501 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/14/2018 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 06/26/2018 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/21/2017 |
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 |
|
|