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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 Problems Loss of or Failure to Bond (1068); Device Dislodged or Dislocated (2923); Human-Device Interface Problem (2949); Moisture or Humidity Problem (2986)
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 patch came off after being sweaty and taking a shower.The patient reported proper technique for insertion of the patch.There was no indication that an adverse event had occurred.This complaint is being reported because the adhesive issue remained unresolved.
 
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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 Key4922062
MDR Text Key22503551
Report Number3008272700-2015-00022
Device Sequence Number1
Product Code OPP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111924
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Report Date 07/11/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2015
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 Received07/11/2015
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 Unknown
Patient Sequence Number1
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