KETONE STRIP, KETONE 50CT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-11-06 for KETONE STRIP, KETONE 50CT manufactured by Trividia Health Inc.

MAUDE Entry Details

Report Number1000113657-2019-10128
MDR Report Key9284507
Report SourceCONSUMER
Date Received2019-11-06
Date of Report2019-11-06
Date of Event2019-10-11
Date Facility Aware2019-10-11
Date Mfgr Received2019-10-11
Date Added to Maude2019-11-06
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 ContactKAREN DEVINCENT
Manufacturer Street2400 NW 55TH COURT
Manufacturer CityFORT LAUDERDALE FL 33309
Manufacturer CountryUS
Manufacturer Postal33309
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameKETONE
Generic NameSYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER
Product CodeJIN
Date Received2019-11-06
Model NumberSTRIP, KETONE 50CT
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerTRIVIDIA HEALTH INC
Manufacturer Address2400 NW 55TH COURT FORT LAUDERDALE FL 33309 US 33309


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-06

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