Brand Name | NI |
Type of Device | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY |
Manufacturer (Section D) |
BAXTER HEALTHCARE CORPORATION |
deerfield IL |
|
Manufacturer (Section G) |
BAXTER HEALTHCARE CORPORATION |
ni |
ni |
ni |
|
Manufacturer Contact |
|
25212 w. illinois route 120 |
round lake, IL
|
2242702068
|
|
MDR Report Key | 13807854 |
MDR Text Key | 287405666 |
Report Number | 1416980-2022-01179 |
Device Sequence Number | 1 |
Product Code |
FKX
|
Combination Product (y/n) | N |
Reporter Country Code | SW |
PMA/PMN Number | NI |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Consumer,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
03/17/2022 |
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 |
Lay User/Patient
|
Device Catalogue Number | ASKU |
Device Lot Number | ASKU |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
02/22/2022
|
Initial Date FDA Received | 03/18/2022 |
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 |
Treatment | HOMECHOICE CLARIA |
|
|