Brand Name | EKOSONIC KIT 106CM 12CM TZ |
Type of Device | CATHETER, CONTINUOUS FLUSH |
Manufacturer (Section D) |
BOSTON SCIENTIFIC CORPORATION |
two scimed place |
maple grove MN 55311 |
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC CORPORATION |
2546 calle primera |
|
alajuela |
CS
|
|
Manufacturer Contact |
jay
johnson
|
two scimed place |
maple grove, MN 55311
|
7634942574
|
|
MDR Report Key | 12702901 |
MDR Text Key | 278525520 |
Report Number | 2134265-2021-13284 |
Device Sequence Number | 1 |
Product Code |
KRA
|
UDI-Device Identifier | 00858593006134 |
UDI-Public | 00858593006134 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K182324 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
11/24/2021 |
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 Expiration Date | 07/18/2024 |
Device Model Number | 500-55112 |
Device Catalogue Number | 500-55112 |
Device Lot Number | 8035040742 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
10/01/2021 |
Initial Date FDA Received | 10/27/2021 |
Supplement Dates Manufacturer Received | 11/04/2021
|
Supplement Dates FDA Received | 11/29/2021
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/19/2021 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |