FINESSE PATCH

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-13 for FINESSE PATCH manufactured by Calibra Medical, Inc.

Event Text Entries

[36220102] (b)(6). 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.
Patient Sequence No: 1, Text Type: N, H10


[36220103] On (b)(6) 2015, it was reported that the device jammed half way through dosing. It was said that the patient replaced the device with a new one, and continued dosing. There was no indication that the product caused or contributed to an adverse event. This complaint is being reported because the device was unable to deliver insulin.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008272700-2016-00001
MDR Report Key5364322
Date Received2016-01-13
Date of Report2015-12-29
Date Mfgr Received2015-12-29
Date Added to Maude2016-01-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSAM CRAWFORD
Manufacturer Street220 SAGINAW DR
Manufacturer CityREDWOOD CITY CA 940634725
Manufacturer CountryUS
Manufacturer Postal940634725
Manufacturer Phone6502984705
Manufacturer G1CALIBRA MEDICAL, INC
Manufacturer Street220 SAGINAW DR
Manufacturer CityREDWOOD CITY CA 940634725
Manufacturer CountryUS
Manufacturer Postal Code940634725
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameFINESSE PATCH
Generic NameFINESSE INSULIN DELIVERYSYSTEM
Product CodeOPP
Date Received2016-01-13
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No0
Device Event Key0
ManufacturerCALIBRA MEDICAL, INC
Manufacturer Address220 SAGINAW DR REDWOOD CITY CA 940634725 US 940634725


Patients

Patient NumberTreatmentOutcomeDate
10 2016-01-13

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