HUDSON NEONATE DUAL HEATED DUAL DRAIN 880-15KIT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-11-14 for HUDSON NEONATE DUAL HEATED DUAL DRAIN 880-15KIT manufactured by Teleflex Medical.

MAUDE Entry Details

Report Number3004365956-2019-00327
MDR Report Key9322020
Report SourceUSER FACILITY
Date Received2019-11-14
Date of Report2019-10-28
Date of Event2019-09-24
Date Mfgr Received2019-10-28
Date Added to Maude2019-11-14
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 ContactVICTORIA SANDLIN
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer G1TELEFLEX MEDICAL
Manufacturer StreetPARQUE INDUSTRIAL FINSA
Manufacturer CityNUEVO LAREDO 88275
Manufacturer CountryMX
Manufacturer Postal Code88275
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHUDSON NEONATE DUAL HEATED DUAL DRAIN
Generic NameHUMIDIFIER NEBULIZER KIT
Product CodeOGG
Date Received2019-11-14
Returned To Mfg2019-10-10
Catalog Number880-15KIT
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressMORRISVILLE NC


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-14

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