Brand Name | BARCO |
Type of Device | NEXXISOR |
Manufacturer (Section D) |
BARCO NV |
president kennedypark 35 |
kortrijk, 8500 |
BE 8500 |
|
Manufacturer (Section G) |
BARCO NV |
president kennedypark 35 |
|
kortrijk, 8500 |
BE
8500
|
|
Manufacturer Contact |
lieven
de wandel
|
president kennedypark 35 |
kortrijk, 8500
|
BE
8500
|
|
MDR Report Key | 18796470 |
MDR Text Key | 336421557 |
Report Number | 3004455125-2024-00005 |
Device Sequence Number | 1 |
Product Code |
DXJ
|
Combination Product (y/n) | N |
Reporter Country Code | QA |
PMA/PMN Number | K173381 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Distributor |
Reporter Occupation |
Other
|
Remedial Action |
Modification/Adjustment |
Type of Report
| Initial |
Report Date |
02/26/2024 |
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 Model Number | MNA-440 ENC / NEXXISOR |
Device Catalogue Number | K9303300 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
04/26/2023
|
Initial Date FDA Received | 02/28/2024 |
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|