AIA-360 019945

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-27 for AIA-360 019945 manufactured by Tosoh Bioscience, Inc..

MAUDE Entry Details

Report Number3005529799-2020-00009
MDR Report Key9766926
Report SourceDISTRIBUTOR
Date Received2020-02-27
Date of Report2020-02-25
Date of Event2019-09-03
Date Mfgr Received2020-02-02
Device Manufacturer Date2017-02-28
Date Added to Maude2020-02-27
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 ContactMS. OCONNELL
Manufacturer Street6000 SHORELINE COURT SUITE 101
Manufacturer CitySOUTH SAN FRANCISCO, CA
Manufacturer CountryUS
Manufacturer Phone6368143
Manufacturer G1TOSOH BIOSCIENCE, INC.
Manufacturer Street3600 GANTZ ROAD
Manufacturer CityGROVE CITY, OH
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAIA-360
Generic NameAIA-360
Product CodeKHO
Date Received2020-02-27
Model NumberAIA-360
Catalog Number019945
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerTOSOH BIOSCIENCE, INC.
Manufacturer Address3600 GANTZ ROAD GROVE CITY, OH US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-27

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