Brand Name | NXSTAGE SYSTEM ONE |
Type of Device | HIGH PERMEABILITY HEMODIALYSIS SYSTEM |
Manufacturer (Section D) |
NXSTAGE MEDICAL, INC. |
350 merrimack street |
lawrence MA 01843 |
|
Manufacturer (Section G) |
MEDIMEXICO S. DE R. L. DE C. V |
av. valle imperial no. 10523 |
parque industrial valle sur |
tijuana 22180 |
MX
22180
|
|
Manufacturer Contact |
paula
rogalski
|
nxstage medical, inc. |
350 merrimack street |
lawrence, MA 01843
|
|
MDR Report Key | 15248231 |
MDR Text Key | 298122257 |
Report Number | 3003464075-2022-00039 |
Device Sequence Number | 1 |
Product Code |
KDI
|
UDI-Device Identifier | M535CAR170C0 |
UDI-Public | +M535CAR170C0/$$1023204770963 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K140526 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Consumer |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
08/18/2022 |
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 |
Lay User/Patient
|
Device Expiration Date | 10/01/2023 |
Device Model Number | CAR-170-C |
Device Catalogue Number | CAR-170-C |
Device Lot Number | 20477096 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/16/2022 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
07/27/2022 |
Initial Date FDA Received | 08/18/2022 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 05/27/2022 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 60 YR |
Patient Sex | Male |
Patient Weight | 72 KG |