SYSTEM 1E PROCESSOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-20 for SYSTEM 1E PROCESSOR manufactured by Steris Canada Corporation.

MAUDE Entry Details

Report Number9680353-2020-00016
MDR Report Key9859628
Report SourceUSER FACILITY
Date Received2020-03-20
Date of Report2020-03-20
Date of Event2020-02-22
Date Mfgr Received2020-02-22
Date Added to Maude2020-03-20
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 ContactMR. DANIEL DAVY
Manufacturer Street5960 HEISLEY ROAD
Manufacturer CityMENTOR, OH
Manufacturer CountryUS
Manufacturer Phone3927453
Manufacturer G1STERIS CANADA CORPORATION
Manufacturer Street490, ARMAND-PARIS
Manufacturer CityQUEBEC, GIC 8A3
Manufacturer CountryCA
Manufacturer Postal CodeGIC 8A3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSYSTEM 1E PROCESSOR
Generic NameSYSTEM 1E PROCESSOR
Product CodeMED
Date Received2020-03-20
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSTERIS CANADA CORPORATION
Manufacturer Address490 ARMAND-PARIS QUEBEC, GIC 8A3 CA GIC 8A3


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-20

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