Brand Name | IMPRESS BRAIDED CATHETER |
Type of Device | IMPRESS |
Manufacturer (Section D) |
MERIT MEDICAL SYSTEMS MEXICO |
8830 siempre viva rd #100 |
san diego, ca 92154 |
EI 92154 |
|
Manufacturer (Section G) |
MERIT MEDICAL SYSTEMS MEXICO |
8830 siempre viva rd #100 |
|
san diego, ca 92154 |
EI
92154
|
|
Manufacturer Contact |
bryson
heaton bsn, rn.
|
1600 merit parkway |
south jordan, UT 84095
|
|
MDR Report Key | 18993060 |
MDR Text Key | 338815492 |
Report Number | 3011642792-2024-00019 |
Device Sequence Number | 1 |
Product Code |
DQO
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K053171 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,User Facility,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
03/21/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/28/2024 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 56538KA2/JPB |
Device Lot Number | I2593040 |
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 03/28/2024 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 02/13/2024 |
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 |
Patient Outcome(s) |
Required Intervention;
|
|
|