CM320-SERIES CM320-2 CM320WD-CTOM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-11-15 for CM320-SERIES CM320-2 CM320WD-CTOM manufactured by Getinge Disinfection Ab.

MAUDE Entry Details

Report Number9616031-2019-00036
MDR Report Key9327629
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-11-15
Date of Report2019-11-15
Date of Event2019-11-08
Date Mfgr Received2019-11-08
Date Added to Maude2019-11-15
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 StreetLJUNGADALSGATAN 11
Manufacturer CityVAXJO
Manufacturer CountryUS
Manufacturer G1GETINGE DISINFECTION AB
Manufacturer StreetLJUNGADALSGATAN 11
Manufacturer CityVAXJO
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCM320-SERIES
Generic NameDISINFECTOR, MEDICAL DEVICES
Product CodeMEC
Date Received2019-11-15
Model NumberCM320-2
Catalog NumberCM320WD-CTOM
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerGETINGE DISINFECTION AB
Manufacturer AddressLJUNGADALSGATAN 11 VAXJO US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-11-15

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