Brand Name | OMRON 10 SERIES BLOOD PRESSURE MONITOR |
Type of Device | BLOOD PRESSURE MONITOR |
Manufacturer (Section D) |
OMRON HEALTHCARE MANUFACTURING VIETNAM CO., LTD. |
no. 28 vsip ii, st. 2, |
vietnam-singapore indus. park |
hoa phu thu dau mot city, binh duong 82000 0 |
VM 820000 |
|
Manufacturer (Section G) |
OMRON HEALTHCARE MANUFACTURING VIETNAM CO., LTD. |
no. 28 vsip ii, st. 2, |
vietnam-singapore indus. park |
hoa phu thu dau mot city, binh duong 82000 0 |
VM
820000
|
|
Manufacturer Contact |
renee
thornborough
|
1925 w field court |
suite 100 |
lake forest, IL 60045-4824
|
8472475626
|
|
MDR Report Key | 7838779 |
MDR Text Key | 118949950 |
Report Number | 3006852037-2018-00003 |
Device Sequence Number | 1 |
Product Code |
DXN
|
UDI-Device Identifier | 00073796267865 |
UDI-Public | (01)00073796267865 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K133383 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,consum |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
08/27/2018 |
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 |
Lay User/Patient
|
Device Model Number | BP786N |
Device Catalogue Number | BP786N |
Device Lot Number | 20160602280VG |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Distributor Facility Aware Date | 08/27/2018 |
Device Age | 26 MO |
Initial Date Manufacturer Received |
08/27/2018 |
Initial Date FDA Received | 08/31/2018 |
Supplement Dates Manufacturer Received | 10/30/2018
|
Supplement Dates FDA Received | 11/01/2018
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/01/2016 |
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 |
Patient Outcome(s) |
Death;
|
|
|