ARGYLE POLYURETHANE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-26 for ARGYLE POLYURETHANE manufactured by Covidien Manufacturing Solutions Sa.

MAUDE Entry Details

Report Number9375262
MDR Report Key9375262
Date Received2019-11-26
Date of Report2019-11-15
Date of Event2019-11-11
Report Date2019-11-15
Date Reported to FDA2019-11-15
Date Reported to Mfgr2019-11-26
Date Added to Maude2019-11-26
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameARGYLE POLYURETHANE
Generic NameCATHETER, UMBILICAL ARTERY
Product CodeFOS
Date Received2019-11-26
Lot Number1916800103
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age1 DA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN MANUFACTURING SOLUTIONS SA
Manufacturer Address15 HAMPSHIRE ST MANSFIELD MA 02048 US 02048


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-26

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