200ML ODYSSEY SYRINGE KIT 60728656 CTP-200-FLS

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 2020-03-23 for 200ML ODYSSEY SYRINGE KIT 60728656 CTP-200-FLS manufactured by Bayer Medical Care Inc..

MAUDE Entry Details

Report Number2520313-2020-00015
MDR Report Key9869155
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-23
Date of Report2020-03-23
Date of Event2020-03-10
Date Mfgr Received2020-03-10
Device Manufacturer Date2019-10-08
Date Added to Maude2020-03-23
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 ContactDIANE ECKERT
Manufacturer Street1 BAYER DRIVE
Manufacturer CityINDIANOLA PA 15051
Manufacturer CountryUS
Manufacturer Postal15051
Manufacturer Phone7249408677
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 Name200ML ODYSSEY SYRINGE KIT
Generic NameANGIOGRAPHIC SYRINGE KIT
Product CodeDXT
Date Received2020-03-23
Returned To Mfg2020-03-16
Model Number60728656
Catalog NumberCTP-200-FLS
Lot Number8412332
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBAYER MEDICAL CARE INC.
Manufacturer Address1 BAYER DRIVE INDIANOLA PA 15051 US 15051


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-23

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