Type of Device | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM |
Manufacturer (Section D) |
NXSTAGE MEDICAL, INC |
350 merrimack street |
lawrence MA 01843 |
|
MDR Report Key | 9563664 |
MDR Text Key | 174150429 |
Report Number | 9563664 |
Device Sequence Number | 1 |
Product Code |
KDI
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
12/19/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 12/19/2019 |
Event Location |
Hospital
|
Date Report to Manufacturer | 01/08/2020 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 01/08/2020 |
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|