WARMING CABINETS 5624 SZ5624XBR

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 2020-02-28 for WARMING CABINETS 5624 SZ5624XBR manufactured by Getinge Ic Production Poland Sp. Z O.o..

MAUDE Entry Details

Report Number3012068831-2020-00002
MDR Report Key9769494
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2020-02-28
Date of Report2020-02-28
Date of Event2020-02-25
Date Mfgr Received2020-02-25
Date Added to Maude2020-02-28
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 NameWARMING CABINETS
Generic NameWARMER, IRRIGATION SOLUTION
Product CodeLHC
Date Received2020-02-28
Model Number5624
Catalog NumberSZ5624XBR
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
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
101. Other 2020-02-28

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