88-SERIES 88-5

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 2019-10-23 for 88-SERIES 88-5 manufactured by Getinge Disinfection Ab.

MAUDE Entry Details

Report Number9616031-2019-00031
MDR Report Key9223706
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-10-23
Date of Report2019-11-15
Date of Event2019-10-16
Date Mfgr Received2019-10-21
Device Manufacturer Date2014-10-14
Date Added to Maude2019-10-23
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
Remedial ActionNO
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name88-SERIES
Generic NameDISINFECTOR, MEDICAL DEVICES
Product CodeMEC
Date Received2019-10-23
Model Number88-5
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerGETINGE DISINFECTION AB
Manufacturer AddressLJUNGADALSGATAN 11 VAXJO US


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-23

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