STELLANT DUAL CT INJECTOR 59879956 SCT DX

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-10-14 for STELLANT DUAL CT INJECTOR 59879956 SCT DX manufactured by Bayer Medical Care.

MAUDE Entry Details

Report Number2520313-2019-00045
MDR Report Key9186044
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-10-14
Date of Report2019-10-14
Date of Event2019-09-20
Date Mfgr Received2019-09-20
Device Manufacturer Date2005-09-22
Date Added to Maude2019-10-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSUSAN SHERWIN
Manufacturer Street1 BAYER DRIVE
Manufacturer CityINDIANOLA PA 15051
Manufacturer CountryUS
Manufacturer Postal15051
Manufacturer Phone7249408678
Manufacturer G1BAYER MEDICAL CARE, INC.
Manufacturer Street1 BAYER DRIVE
Manufacturer CityINDIANOLA PA 15051
Manufacturer CountryUS
Manufacturer Postal Code15051
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSTELLANT DUAL CT INJECTOR
Generic NameCT INJECTION SYSTEM
Product CodeDXT
Date Received2019-10-14
Model Number59879956
Catalog NumberSCT DX
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBAYER MEDICAL CARE
Manufacturer Address1 BAYER DRIVE INDIANOLA PA 15051 US 15051


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-10-14

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