UMBILICAL CATHETER 270.04

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-09-20 for UMBILICAL CATHETER 270.04 manufactured by Vygon.

MAUDE Entry Details

Report Number2245270-2019-00056
MDR Report Key9097387
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-09-20
Date of Report2019-09-10
Date of Event2019-08-21
Date Mfgr Received2019-08-22
Date Added to Maude2019-09-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactFREDA LACROIX
Manufacturer Street2750 MORRIS ROAD
Manufacturer CityLANSDALE PA 19446
Manufacturer CountryUS
Manufacturer Postal19446
Manufacturer Phone8004735414
Manufacturer G1VYGON
Manufacturer Street5 RUE ADELINE
Manufacturer CityECOUEN, 95440
Manufacturer CountryFR
Manufacturer Postal Code95440
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUMBILICAL CATHETER
Generic NameUMBILICAL CATHETER
Product CodeFOS
Date Received2019-09-20
Model Number270.04
Catalog Number270.04
Lot Number180718FQ
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerVYGON
Manufacturer Address5 RUE ADELINE ECOUEN, 95440 FR 95440


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-09-20

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