UMBILI-CATH DUAL-LUMEN SILICONE 4273505

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-19 for UMBILI-CATH DUAL-LUMEN SILICONE 4273505 manufactured by Utah Medical Products, Inc..

MAUDE Entry Details

Report Number8806988
MDR Report Key8806988
Date Received2019-07-19
Date of Report2019-07-09
Date of Event2019-04-15
Report Date2019-07-09
Date Reported to FDA2019-07-09
Date Reported to Mfgr2019-07-19
Date Added to Maude2019-07-19
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUMBILI-CATH
Generic NameCATHETER, UMBILICAL ARTERY
Product CodeFOS
Date Received2019-07-19
Model NumberDUAL-LUMEN SILICONE
Catalog Number4273505
Lot Number1182062
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerUTAH MEDICAL PRODUCTS, INC.
Manufacturer Address7043 SOUTH 300 WEST MIDVALE UT 84047 US 84047


Patients

Patient NumberTreatmentOutcomeDate
10 2019-07-19

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