Brand Name | POLARIS ULTRA |
Type of Device | STENT, URETERAL |
Manufacturer (Section D) |
BOSTON SCIENTIFIC CORPORATION |
300 boston scientific way |
marlborough MA 01752 |
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC CORPORATION |
2546 calle primera |
|
alajuela |
CS
|
|
Manufacturer Contact |
farshad
fahimi
|
4100 hamline avenue north |
building c |
saint paul, MN 55112
|
|
MDR Report Key | 18962020 |
MDR Text Key | 338456343 |
Report Number | 2124215-2024-15594 |
Device Sequence Number | 1 |
Product Code |
FAD
|
UDI-Device Identifier | 08714729124320 |
UDI-Public | 08714729124320 |
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K010002 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Health Professional,Company Representative,Distributor |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
03/22/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/22/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | M0061921230 |
Device Catalogue Number | 192-123 |
Device Lot Number | 0031209361 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 02/26/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/10/2023 |
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 Age | 53 YR |
Patient Sex | Male |
Patient Weight | 61 KG |
|
|