Brand Name | LONG-TERM HEMODIALYSIS CATHETER |
Type of Device | HEMODIALYSIS CATHETER |
Manufacturer (Section D) |
MERIT MEDICAL SYSTEMS INC. |
1600 merit parkway |
south jordan, UT 84095 |
|
Manufacturer (Section G) |
MERIT MEDICAL SYSTEMS INC. |
1600 merit parkway |
|
south jordan, UT 84095 |
|
Manufacturer Contact |
david
lockridge
|
1600 merit parkway |
south jordan, UT 84095
|
8012084551
|
|
MDR Report Key | 9176890 |
MDR Text Key | 163048333 |
Report Number | 1721504-2019-00086 |
Device Sequence Number | 1 |
Product Code |
MSD
|
UDI-Device Identifier | 00884450038185 |
UDI-Public | 00884450038185 |
Combination Product (y/n) | N |
Reporter Country Code | TH |
PMA/PMN Number | K141363 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
09/19/2019 |
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 Catalogue Number | CENFP19K |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/19/2019 |
Initial Date FDA Received | 10/10/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |
|
|