Brand Name | REVACLEAR |
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 - OPELIKA |
1101 jeter ave |
|
opelika AL 36801 |
|
Manufacturer Contact |
|
25212 w. illinois route 120 |
round lake, IL 60073
|
2242702068
|
|
MDR Report Key | 16015153 |
MDR Text Key | 308117266 |
Report Number | 3006552611-2022-00035 |
Device Sequence Number | 1 |
Product Code |
KDI
|
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K130039 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Nurse Practitioner
|
Type of Report
| Initial,Followup |
Report Date |
01/12/2023 |
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 |
Health Professional
|
Device Catalogue Number | 114749M |
Device Lot Number | C422203401 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Initial Date Manufacturer Received |
11/29/2022 |
Initial Date FDA Received | 12/20/2022 |
Supplement Dates Manufacturer Received | 01/05/2023
|
Supplement Dates FDA Received | 01/12/2023
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/26/2022 |
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 |