PROLYSTICA 2X CONCENTRATE ENZYMATIC PRESOAK AND CLEANER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-28 for PROLYSTICA 2X CONCENTRATE ENZYMATIC PRESOAK AND CLEANER manufactured by Steris Corporation.

MAUDE Entry Details

Report Number1937531-2019-00002
MDR Report Key8940893
Date Received2019-08-28
Date of Report2019-08-28
Date of Event2019-07-31
Date Mfgr Received2019-07-31
Date Added to Maude2019-08-28
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 CORPORATION
Manufacturer Street7501 PAGE AVENUE
Manufacturer CityST. LOUIS MO 63133
Manufacturer CountryUS
Manufacturer Postal Code63133
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NamePROLYSTICA 2X CONCENTRATE ENZYMATIC PRESOAK AND CLEANER
Generic NameCLEANER
Product CodeFLG
Date Received2019-08-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSTERIS CORPORATION
Manufacturer Address7501 PAGE AVENUE ST. LOUIS MO 63133 US 63133


Patients

Patient NumberTreatmentOutcomeDate
10 2019-08-28

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.