Brand Name | MERIT CUSTOM KIT |
Type of Device | CUSTOM KIT |
Manufacturer (Section D) |
MERIT MEDICAL SYSTEMS, INC. |
1600 w merit parkway |
south jordan 84095 |
|
Manufacturer (Section G) |
MERIT MEDICAL SYSTEMS, INC. |
1600 w merit parkway |
|
south jordan 84095 |
|
Manufacturer Contact |
katie
swenson, cqe, cba, cqpa
|
1600 w merit parkway |
south jordan 84095
|
8012081600
|
|
MDR Report Key | 7421614 |
MDR Text Key | 105156019 |
Report Number | 1721504-2018-00031 |
Device Sequence Number | 1 |
Product Code |
DQO
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
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? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 09/30/2020 |
Device Catalogue Number | K09-10716C |
Device Lot Number | H1279556 |
Was Device Available for Evaluation? |
No
|
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 | 04/11/2018 |
Supplement Dates Manufacturer Received | 06/11/2018
|
Supplement Dates FDA Received | 06/14/2018
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/18/2018 |
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 |
Patient Outcome(s) |
Life Threatening;
|
|
|