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 | 8578792 |
MDR Text Key | 144271093 |
Report Number | 1721504-2019-00030 |
Device Sequence Number | 1 |
Product Code |
OJA
|
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 |
Report Date |
03/20/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/03/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 09/30/2021 |
Device Catalogue Number | K04-MZL6501 |
Device Lot Number | H1434618 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/16/2019 |
Date Manufacturer Received | 04/19/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/11/2019 |
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 |
|
|