Brand Name | EKOSONIC KIT 106CM 24CM TZ |
Type of Device | CATHETER, CONTINUOUS FLUSH |
Manufacturer (Section D) |
EKOS CORPORATION |
11911 north creek parkway s. |
bothell WA 98011 |
|
Manufacturer (Section G) |
EKOS CORPORATION |
11911 north creek pkwy south |
|
bothell WA 98011 |
|
Manufacturer Contact |
jay
johnson
|
two scimed place |
maple grove, MN 55311
|
7634942574
|
|
MDR Report Key | 10393259 |
MDR Text Key | 202520235 |
Report Number | 2134265-2020-10440 |
Device Sequence Number | 1 |
Product Code |
KRA
|
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 |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
08/11/2020 |
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 | 500-55124 |
Device Catalogue Number | 500-55124 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/21/2020 |
Initial Date FDA Received | 08/11/2020 |
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 |