Brand Name | HOMECHOICE AUTOMATED PD SET WITH CASSETTE |
Type of Device | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY |
Manufacturer (Section D) |
BAXTER HEALTHCARE CORPORATION |
deerfield IL |
|
Manufacturer (Section G) |
BAXTER HEALTHCARE - ATLACOMULCO |
av. ing. salvador sanchez |
colin no. 9 |
atlacomulco CP 50 450 |
MX
CP 50450
|
|
Manufacturer Contact |
|
25212 w. illinois route 120 |
round lake, IL 60073
|
2242702068
|
|
MDR Report Key | 16035461 |
MDR Text Key | 308204597 |
Report Number | 1416980-2022-07016 |
Device Sequence Number | 1 |
Product Code |
FKX
|
Combination Product (y/n) | N |
Reporter Country Code | MX |
PMA/PMN Number | NA |
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,Followup |
Report Date |
01/25/2023 |
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 | BBC8314P |
Device Lot Number | 40DIHC |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
11/25/2022 |
Initial Date FDA Received | 12/22/2022 |
Supplement Dates Manufacturer Received | 01/24/2023
|
Supplement Dates FDA Received | 01/25/2023
|
Was Device Evaluated by Manufacturer? |
No
|
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 | UNSPECIFIED PD SOLUTION |
|
|