Brand Name | PRISMAFLEX M100 SET |
Type of Device | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM |
Manufacturer (Section D) |
BAXTER HEALTHCARE CORPORATION |
deerfield IL |
|
Manufacturer (Section G) |
BAXTER HEALTHCARE - MEYZIEU |
7, av lionel terray, b.p. 126 |
|
meyzieu cedex rhone 69883 |
FR
69883
|
|
Manufacturer Contact |
|
25212 w. illinois route 120 |
round lake, IL
|
2242702068
|
|
MDR Report Key | 12972771 |
MDR Text Key | 284115688 |
Report Number | 8010182-2021-00396 |
Device Sequence Number | 1 |
Product Code |
KDI
|
UDI-Device Identifier | 07332414124397 |
UDI-Public | (01)07332414124397 |
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | NA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
12/09/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/09/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 04/30/2023 |
Device Catalogue Number | 955595 |
Device Lot Number | 21E0402 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 11/17/2021 |
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 | PRISMAFLEX MACHINE. |
|
|