500-SERIES 533HC

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-08-09 for 500-SERIES 533HC manufactured by Getinge Ic Production Poland Sp. Z O.o..

MAUDE Entry Details

Report Number3012068831-2019-00009
MDR Report Key8878334
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2019-08-09
Date of Report2019-11-15
Date Mfgr Received2019-07-30
Date Added to Maude2019-08-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. DENNIS GENITO
Manufacturer StreetSZKOLNA 30
Manufacturer CityPLEWISKA WIELKOPOLSKIE
Manufacturer CountryUS
Manufacturer G1GETINGE IC PRODUCTION POLAND SP. Z O.O.
Manufacturer StreetSZKOLNA 30
Manufacturer CityPLEWISKA WIELKOPOLSKIE
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name500-SERIES
Generic NameSTERILIZER, STEAM
Product CodeFLE
Date Received2019-08-09
Model Number533HC
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerGETINGE IC PRODUCTION POLAND SP. Z O.O.
Manufacturer AddressSZKOLNA 30 PLEWISKA WIELKOPOLSKIE US


Patients

Patient NumberTreatmentOutcomeDate
10 2019-08-09

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