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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CALIBRA MEDICAL, INC FINESSE PATCH; FINESSE INSULIN DELIVERYSYSTEM
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CALIBRA MEDICAL, INC FINESSE PATCH; FINESSE INSULIN DELIVERYSYSTEM Back to Search Results
Device Problem Bent (1059)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Calibra has been unable to request return of the product at this time.If the device is returned, an evaluation shall be completed and a supplemental report will be filed.No conclusions can be made at this time.
 
Event Description
On (b)(6) 2015, it was reported that the inserter needle was bent after the patient attempted to insert a new device.It could not be determined if the needle was bent before the insertion attempt was made.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because the device became unusable.
 
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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 Key5334268
MDR Text Key35170838
Report Number3008272700-2015-00057
Device Sequence Number1
Product Code OPP
Combination Product (y/n)N
PMA/PMN Number
K111924
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,study
Reporter Occupation Patient
Type of Report Initial
Report Date 12/15/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Manufacturer Received12/15/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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