5.0FR URETHANE UMB CATH 8888160341

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2019-08-13 for 5.0FR URETHANE UMB CATH 8888160341 manufactured by Covidien.

MAUDE Entry Details

Report Number3009211636-2019-00665
MDR Report Key8890358
Report SourceDISTRIBUTOR,FOREIGN,HEALTH PR
Date Received2019-08-13
Date of Report2019-08-13
Date Mfgr Received2019-07-15
Date Added to Maude2019-08-13
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 ContactJILL SARAIVA
Manufacturer Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone5086183640
Manufacturer G1COVIDIEN
Manufacturer StreetEDIFICIO B20 CALLE #2 ZONA FRA
Manufacturer CityALAJUELA
Manufacturer CountryCS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name5.0FR URETHANE UMB CATH
Generic NameCATHETER, UMBILICAL ARTERY
Product CodeFOS
Date Received2019-08-13
Model Number8888160341
Catalog Number8888160341
Lot NumberUNKNOWN
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer AddressEDIFICIO B20 CALLE #2 ZONA FRA ALAJUELA CS


Patients

Patient NumberTreatmentOutcomeDate
10 2019-08-13

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