KETONE STRIPS NA

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 2019-06-20 for KETONE STRIPS NA manufactured by Trividia Health, Inc..

MAUDE Entry Details

Report Number1000113657-2019-00650
MDR Report Key8719716
Report SourceCONSUMER
Date Received2019-06-20
Date of Report2019-06-20
Date of Event2018-02-01
Date Mfgr Received2019-05-28
Date Added to Maude2019-06-20
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
Manufacturer Phone954677-920
Single Use3
Remedial ActionRL
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameKETONE STRIPS
Generic NameBLOOD GLUCOSE SYSTEM
Product CodeJIN
Date Received2019-06-20
Returned To Mfg2018-02-08
Model NumberKETONE STRIPS
Catalog NumberNA
Lot NumberAU365
Device Expiration Date2019-02-13
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTRIVIDIA HEALTH, INC.
Manufacturer Address2400 NW 55TH COURT FORT LAUDERDALE FL 33309 US 33309


Patients

Patient NumberTreatmentOutcomeDate
10 2019-06-20

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