HENRY SCHEIN MONO TEST DEVICE 20T IMO-402

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2020-03-31 for HENRY SCHEIN MONO TEST DEVICE 20T IMO-402 manufactured by Alere San Diego.

MAUDE Entry Details

Report Number2027969-2020-00017
MDR Report Key9908585
Report SourceDISTRIBUTOR,HEALTH PROFESSION
Date Received2020-03-31
Date of Report2020-03-31
Date Mfgr Received2020-03-25
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMONIKA BURRELL
Manufacturer Street9975 SUMMERS RIDGE ROAD
Manufacturer CitySAN DIEGO, CA
Manufacturer CountryUS
Manufacturer Phone8052506
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHENRY SCHEIN MONO TEST DEVICE 20T
Generic NameMONONUCLEOSIS REAGENT TEST KIT
Product CodeKTN
Date Received2020-03-31
Model NumberIMO-402
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerALERE SAN DIEGO
Manufacturer Address9975 SUMMERS RIDGE RD SAN DIEGO, CA US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-31

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