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 2015-07-17 for FINESSE PATCH manufactured by Calibra Medical, Inc.

Event Text Entries

[22503616] The product has not been returned to calibra. 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


[22503617] On (b)(6) 2015 the reporter responded to an anonymous survey for calibra indicating that physical labor had caused sweating which caused the patch to come loose. The reporter indicated using a backup treatment plan until a new patch could be applied. This complaint is being reported because the reported issue was not resolved with troubleshooting. There was no indication that the product caused or contributed to an adverse event.
Patient Sequence No: 1, Text Type: D, B5


[27543408] Follow up #1 submitted 08/26/2015: calibra received follow up from the patient on 08/19/2015. The patient indicated that the sites were prepared by washing the site but no alcohol wipes were used. The patient also indicated that hair was not removed from the site prior to application. The patient indicated that the patches typically fell off because of excess sweat. The patient indicated that the adhesive was loosening and coming off from underneath and not really from the outside edges unless the site was bumped.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3008272700-2015-00018
MDR Report Key4921733
Date Received2015-07-17
Date of Report2015-07-06
Date Mfgr Received2015-07-06
Date Added to Maude2015-07-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
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 Report3

Device Details

Brand NameFINESSE PATCH
Generic NameFINESSE INSULIN DELIVERYSYSTEM
Product CodeOPP
Date Received2015-07-17
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCALIBRA MEDICAL, INC
Manufacturer Address220 SAGINAW DR REDWOOD CITY CA 940634725 US 940634725


Patients

Patient NumberTreatmentOutcomeDate
10 2015-07-17

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