Brand Name | MERIT CUSTOM KIT |
Type of Device | CATHETER, INTRAVASCULAR, DIAGNOSTIC |
Manufacturer (Section D) |
MERIT MEDICAL SYSTEMS INC |
south jordan UT |
|
Manufacturer (Section G) |
MERIT MEDICAL IRELAND, LTD. |
|
|
|
|
Manufacturer Contact |
jerry
mcphie
|
1600 west merit parkway |
south jordan, UT 84095
|
8012084491
|
|
MDR Report Key | 4016984 |
MDR Text Key | 19591461 |
Report Number | 9616662-2014-00009 |
Device Sequence Number | 1 |
Product Code |
DQO
|
Combination Product (y/n) | N |
PMA/PMN Number | K913682 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Company Representative,Distributor |
Reporter Occupation |
Not Applicable
|
Type of Report
| Initial |
Report Date |
07/03/2014 |
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 | 03/31/2017 |
Device Catalogue Number | MAP112 |
Device Lot Number | K618478 |
Was Device Available for Evaluation? |
Yes
|
Date Returned to Manufacturer | 07/15/2014 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
07/03/2014
|
Initial Date FDA Received | 07/31/2014 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 06/01/2014 |
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 |
|
|