AMSCO 400 STERILIZER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-10 for AMSCO 400 STERILIZER manufactured by Steris Mexico, S. De R.l. De C.v..

MAUDE Entry Details

Report Number3005899764-2019-00066
MDR Report Key8776287
Date Received2019-07-10
Date of Report2019-07-10
Date of Event2019-06-11
Date Mfgr Received2019-06-11
Date Added to Maude2019-07-10
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 44060
Manufacturer CountryUS
Manufacturer Postal44060
Manufacturer Phone4403927453
Manufacturer G1STERIS MEXICO, S. DE R.L. DE C.V.
Manufacturer StreetAVENIDA AVANTE 790 PARQUE INDUSTRIAL GUADALUPE
Manufacturer CityGUADALUPE, 67190
Manufacturer CountryMX
Manufacturer Postal Code67190
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameAMSCO 400 STERILIZER
Generic NameSTERILIZER
Product CodeFLE
Date Received2019-07-10
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSTERIS MEXICO, S. DE R.L. DE C.V.
Manufacturer AddressAVENIDA AVANTE 790 PARQUE INDUSTRIAL GUADALUPE GUADALUPE, 67190 MX 67190


Patients

Patient NumberTreatmentOutcomeDate
10 2019-07-10

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