AUTOMATION LOADING SYSTEM AGS

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 2019-08-06 for AUTOMATION LOADING SYSTEM AGS manufactured by Getinge Disinfection Ab.

MAUDE Entry Details

Report Number9616031-2019-00020
MDR Report Key8863493
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2019-08-06
Date of Report2019-09-26
Date Mfgr Received2019-07-01
Device Manufacturer Date2004-08-25
Date Added to Maude2019-08-06
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 StreetLJUNGADALSGATAN 11
Manufacturer CityVAXJO
Manufacturer CountryUS
Manufacturer G1GETINGE DISINFECTION AB
Manufacturer StreetLJUNGADALSGATAN 11
Manufacturer CityVAXJO
Manufacturer CountryUS
Single Use3
Remedial ActionRL
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAUTOMATION LOADING SYSTEM
Generic NameSTERILIZER AUTOMATED LOADING SYSTEM
Product CodePEC
Date Received2019-08-06
Model NumberAGS
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 2019-08-06

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