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
|
9784505276
|
|
MDR Report Key | 9124132 |
MDR Text Key | 166127697 |
Report Number | 3003464075-2019-00049 |
Device Sequence Number | 1 |
Product Code |
KDI
|
UDI-Device Identifier | M535CAR172C0 |
UDI-Public | +M535CAR172C0/$$1020901770281 |
Combination Product (y/n) | Y |
Reporter Country Code | SW |
PMA/PMN Number | K140526 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign,health pr |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
01/01/2005,09/26/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 10/01/2020 |
Device Model Number | CAR-172-C |
Device Catalogue Number | CAR-172-C |
Device Lot Number | 90177028 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 01/01/2005 |
Date Report to Manufacturer | 01/10/2005 |
Initial Date Manufacturer Received |
09/19/2019 |
Initial Date FDA Received | 09/26/2019 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 68 YR |
Patient Weight | 71 |