Brand Name | ONETOUCH ULTRA BLUE STRIPS |
Type of Device | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER |
Manufacturer (Section D) |
|
MDR Report Key | 9948013 |
MDR Text Key | 187439527 |
Report Number | MW5094091 |
Device Sequence Number | 1 |
Product Code |
NBW
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
04/07/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/09/2020 |
Is this an Adverse Event Report? |
Yes
|
Device Operator |
No Information
|
Is the Reporter a Health Professional? |
Yes
|
Was Device Evaluated by Manufacturer? |
No Information
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|