CATH PKGD: THERMISTOR 5 80CM AI-07165

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 2019-11-04 for CATH PKGD: THERMISTOR 5 80CM AI-07165 manufactured by Arrow International Inc..

MAUDE Entry Details

Report Number3010532612-2019-00384
MDR Report Key9273065
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-11-04
Date of Report2019-10-07
Date of Event2019-10-07
Date Mfgr Received2019-10-07
Device Manufacturer Date2019-08-28
Date Added to Maude2019-11-04
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 ContactCARMEN SHERMAN
Manufacturer Street16 ELIZABETH DRIVE
Manufacturer CityCHELMSFORD MA 01824
Manufacturer CountryUS
Manufacturer Postal01824
Manufacturer Phone9782505100
Manufacturer G1ARROW INTERNATIONAL INC.
Manufacturer Street16 ELIZABETH DRIVE
Manufacturer CityCHELMSFORD MA 01824
Manufacturer CountryUS
Manufacturer Postal Code01824
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCATH PKGD: THERMISTOR 5 80CM
Generic NameCATHETER, FLOW DIRECTED
Product CodeDYG
Date Received2019-11-04
Returned To Mfg2019-10-09
Catalog NumberAI-07165
Lot Number16F19H0127
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerARROW INTERNATIONAL INC.
Manufacturer AddressREADING PA


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-04

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