Brand Name | DBB-06 HEMODIALYSIS DELIVERY SYSTEM |
Type of Device | HIGH PERMEABILITY HEMODIALYZER |
Manufacturer (Section D) |
NIKKISO CO.,LTD |
20-3, ebisu 4-chome |
shibuya-ku |
tokyo, 150-6 022 |
JA 150-6022 |
|
Manufacturer (Section G) |
NIKKISO CO.,LTD |
498-1 shizutani |
makinohara-shi |
shizuoka, 421-0 496 |
JA
421-0496
|
|
Manufacturer Contact |
toshio
ohmori
|
20-3, ebisu 4-chome |
shibuya-ku |
tokyo, 150-6-022
|
JA
150-6022
|
|
MDR Report Key | 10982697 |
MDR Text Key | 220640042 |
Report Number | 8031561-2020-00003 |
Device Sequence Number | 1 |
Product Code |
KDI
|
Combination Product (y/n) | N |
Reporter Country Code | AS |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign,user faci |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
12/10/2020 |
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 Model Number | DBB-06 |
Device Catalogue Number | N/A |
Device Lot Number | N/A |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/02/2014 |
Initial Date FDA Received | 12/10/2020 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Treatment | BLOOD TUBING LINE : AV06JE-PDIALYZER |
Patient Outcome(s) |
Other;
|
|
|