Brand Name | MERIT CUSTOM KIT |
Type of Device | CATHETER, INTRAVASCULAR, DIAGNOSTIC |
Manufacturer (Section D) |
MERIT MEDICAL SYSTEMS, INC. |
south jordan UT |
|
Manufacturer Contact |
jerry
mcphie
|
1600 west merit pkwy |
south jordan, UT 84095
|
8012084491
|
|
MDR Report Key | 3944073 |
MDR Text Key | 16540655 |
Report Number | 1125782-2014-00001 |
Device Sequence Number | 1 |
Product Code |
DQO
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K913682 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility,Company Representative |
Reporter Occupation |
Not Applicable
|
Type of Report
| Initial |
Report Date |
04/08/2014 |
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 |
Health Professional
|
Device Expiration Date | 08/31/2016 |
Device Catalogue Number | K12T-04870B |
Device Lot Number | T578172 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
04/08/2014 |
Initial Date FDA Received | 05/01/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/01/2014 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|