Brand Name | FINESSE PATCH |
Type of Device | FINESSE INSULIN DELIVERYSYSTEM |
Manufacturer (Section D) |
CALIBRA MEDICAL, INC |
220 saginaw dr |
redwood city CA 94063 4725 |
|
Manufacturer (Section G) |
CALIBRA MEDICAL, INC |
220 saginaw dr |
|
redwood city CA 94063 4725 |
|
Manufacturer Contact |
sam
crawford
|
220 saginaw dr |
redwood city, CA 94063-4725
|
6502984705
|
|
MDR Report Key | 5873185 |
MDR Text Key | 52955074 |
Report Number | 3008272700-2016-00023 |
Device Sequence Number | 1 |
Product Code |
OPP
|
Combination Product (y/n) | N |
PMA/PMN Number | K111924 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer,study |
Reporter Occupation |
Patient
|
Type of Report
| Initial,Followup |
Report Date |
08/01/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Other Device ID Number | 1-2VSIX7R |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/28/2016 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Initial Date Manufacturer Received |
08/01/2016
|
Initial Date FDA Received | 08/12/2016 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 08/17/2016
|
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 |
|
|