Brand Name | MERIT CUSTOM KIT |
Type of Device | MERIT CUSTOM KIT |
Manufacturer (Section D) |
MERIT MEDICAL IRELAND LTD. |
parkmore industrial estate |
ballybrit, |
EI |
|
Manufacturer (Section G) |
MERIT MEDICAL IRELAND LTD. |
parkmore industrial estate |
|
ballybrit, |
EI
|
|
Manufacturer Contact |
casey
hughes ms, cqe
|
avenido sor juana ines de la c |
#19970-b |
colonia parque industrial laf, 19970
|
MX
19970
|
|
MDR Report Key | 6414408 |
MDR Text Key | 70339986 |
Report Number | 9616662-2017-00009 |
Device Sequence Number | 1 |
Product Code |
DQO
|
Combination Product (y/n) | N |
Reporter Country Code | DA |
PMA/PMN Number | K913682 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
02/23/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/17/2017 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Physician
|
Device Expiration Date | 08/31/2018 |
Device Catalogue Number | K12T-07796C |
Device Lot Number | K1048702 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/06/2017 |
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 05/31/2017 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/28/2016 |
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 |
|
|