Brand Name | EXELTRA |
Type of Device | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM |
Manufacturer (Section D) |
NIPRO CORPORATION USD |
ohdate-shi |
|
Manufacturer (Section G) |
NIPRO CORPORATION USD |
8-7 hanuki-yachi, niida-aza |
ni |
ohdate-shi 01857 94 |
JA
0185794
|
|
Manufacturer Contact |
|
25212 w. illinois route 120 |
round lake, IL 60073
|
2242702068
|
|
MDR Report Key | 6722827 |
MDR Text Key | 80334048 |
Report Number | 1416980-2017-05923 |
Device Sequence Number | 1 |
Product Code |
KDI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K030974 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Nurse
|
Type of Report
| Initial,Followup |
Report Date |
09/06/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | 5M2119 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
06/20/2017 |
Initial Date FDA Received | 07/18/2017 |
Supplement Dates Manufacturer Received | 08/14/2017
|
Supplement Dates FDA Received | 09/06/2017
|
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 |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 60 YR |
Patient Weight | 68 |
|
|