NIOFLO CANNULA INFANT 038-13-253U

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 2020-02-14 for NIOFLO CANNULA INFANT 038-13-253U manufactured by Flexicare Medical Dongguan Ltd..

MAUDE Entry Details

Report Number3006061749-2020-00001
MDR Report Key9711005
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-02-14
Date of Report2020-02-14
Date of Event2020-01-15
Date Mfgr Received2020-01-16
Device Manufacturer Date2019-06-01
Date Added to Maude2020-02-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR RICHARD DOWNS
Manufacturer StreetCYNON VALLEY BUSINESS PARK
Manufacturer CityMOUNTAIN ASH, RCT CF454ER
Manufacturer CountryUK
Manufacturer PostalCF45 4ER
Manufacturer G1FLEXICARE MEDICAL DONGGUAN LTD.
Manufacturer StreetNO. B-15 XICHENG IND ZONE 1 HENGLI TOWN
Manufacturer CityDONGGUAN CITY, GUANGDONG 523460
Manufacturer CountryCH
Manufacturer Postal Code523460
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNIOFLO CANNULA INFANT
Generic NameHIGH FLOW NASAL CANNULA
Product CodeCAT
Date Received2020-02-14
Catalog Number038-13-253U
Lot Number190602477
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerFLEXICARE MEDICAL DONGGUAN LTD.
Manufacturer AddressNO. B-15 XICHENG IND ZONE 1 HENGLI TOWN DONGGUAN CITY, GUANGDONG 523460 CH 523460


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-02-14

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.