Brand Name | EASY TOUCH BLOOD GLUCOSE MONITORING SYSTEM |
Type of Device | BLOOD GLUCOSE MONITORING SYSTEM |
Manufacturer (Section D) |
TYSON BIORESEARCH INC. |
5f., no. 16, 18, 20, 22, |
kedong 3rd rd., zhunan, |
miaoli county, taiwan 35053 |
TW 35053 |
|
Manufacturer (Section G) |
TYSON BIORESEARCH INC. |
5f., no. 16, 18, 20, 22, |
kedong 3rd rd., zhunan, |
miaoli county, taiwan 35053 |
TW
35053
|
|
Manufacturer Contact |
vance
chang
|
5f., no. 16, 18, 20, 22, |
kedong 3rd rd., zhunan, |
miaoli county, taiwan 35053
|
TW
35053
|
|
MDR Report Key | 8276812 |
MDR Text Key | 134065299 |
Report Number | 3003132490-2019-00010 |
Device Sequence Number | 1 |
Product Code |
NBW
|
Combination Product (y/n) | N |
Reporter Country Code | TW |
PMA/PMN Number | K101543 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Source Type |
distributor |
Reporter Occupation |
Administrator/Supervisor
|
Remedial Action |
Replace |
Type of Report
| Initial |
Report Date |
01/02/2019,01/23/2019 |
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 |
No Information
|
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Device Age | 1 YR |
Event Location |
Home
|
Date Report to Manufacturer | 01/02/2019 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 01/25/2019 |
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 |
Initial
|
Patient Sequence Number | 1 |
|
|