Brand Name | PRISMAFLEX M100 SET |
Type of Device | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM |
Manufacturer (Section D) |
BAXTER HEALTHCARE - MEYZIEU |
meyzieu cedex rhone |
|
Manufacturer (Section G) |
BAXTER HEALTHCARE - MEYZIEU |
7, av lionel terray, b.p. 126 |
na |
meyzieu cedex rhone 69883 |
FR
69883
|
|
Manufacturer Contact |
|
25212 w. illinois route 120 |
round lake, IL 60073
|
2242702068
|
|
MDR Report Key | 8174613 |
MDR Text Key | 131793283 |
Report Number | 8010182-2018-00175 |
Device Sequence Number | 1 |
Product Code |
KDI
|
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K041005 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Nurse
|
Type of Report
| Initial,Followup |
Report Date |
01/25/2019 |
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 |
Health Professional
|
Device Expiration Date | 04/01/2020 |
Device Catalogue Number | 115306 |
Device Lot Number | 18D2709 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/26/2018 |
Initial Date FDA Received | 12/18/2018 |
Supplement Dates Manufacturer Received | 01/16/2019
|
Supplement Dates FDA Received | 01/25/2019
|
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 04/01/2018 |
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 |
|
|