AMSCO 400

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-14 for AMSCO 400 manufactured by Steris Corporation.

MAUDE Entry Details

Report Number9320747
MDR Report Key9320747
Date Received2019-11-14
Date of Report2019-10-30
Date of Event2019-10-05
Report Date2019-10-31
Date Reported to FDA2019-10-31
Date Reported to Mfgr2019-11-14
Date Added to Maude2019-11-14
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Generic NameSTERILIZER, STEAM
Product CodeFLE
Date Received2019-11-14
Model NumberAMSCO 400
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSTERIS CORPORATION
Manufacturer Address5960 HEISLEY RD. MENTOR OH 44060 US 44060


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-14

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