Brand Name | PRISMAFLEX M150 |
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 60073
|
2242702068
|
|
MDR Report Key | 11041412 |
MDR Text Key | 224781581 |
Report Number | 8010182-2020-00304 |
Device Sequence Number | 1 |
Product Code |
KDI
|
UDI-Device Identifier | 07332414090005 |
UDI-Public | (01)07332414090005 |
Combination Product (y/n) | Y |
Reporter Country Code | US |
PMA/PMN Number | K080519 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
12/18/2020 |
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 | 04/30/2022 |
Device Catalogue Number | 109990 |
Device Lot Number | 20E2401 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/26/2020 |
Initial Date FDA Received | 12/18/2020 |
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 |
Unknown
|
Patient Sequence Number | 1 |