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 | 6414388 |
MDR Text Key | 70323489 |
Report Number | 9616662-2017-00010 |
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 |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Physician
|
Device Catalogue Number | K12T-07796C |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/06/2017 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
02/23/2017
|
Initial Date FDA Received | 03/17/2017 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 06/07/2017
|
Was Device Evaluated by Manufacturer? |
Yes
|
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 |
|
|