Brand Name | HOMECHOICE AUTOMATED PD SET WITH CASSETTE |
Type of Device | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY |
Manufacturer (Section D) |
BAXTER HEALTHCARE - SINGAPORE |
singapore |
|
Manufacturer (Section G) |
BAXTER HEALTHCARE - SINGAPORE |
2 woodlands industrial park d |
|
singapore 73875 0 |
SN
738750
|
|
Manufacturer Contact |
|
25212 w. illinois route 120 |
round lake, IL 60073
|
2242702068
|
|
MDR Report Key | 8520167 |
MDR Text Key | 142130379 |
Report Number | 1416980-2019-02058 |
Device Sequence Number | 1 |
Product Code |
FKX
|
Combination Product (y/n) | N |
Reporter Country Code | SP |
PMA/PMN Number | NA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,consum |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
04/16/2019 |
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 | R5C4479 |
Device Lot Number | S18I07023 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
03/21/2019 |
Initial Date FDA Received | 04/16/2019 |
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 |
N
|
Patient Sequence Number | 1 |
Treatment | HOMECHOICE |