HUDSON THERMAGARD NEBULIZER HEATER 5705

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-01-06 for HUDSON THERMAGARD NEBULIZER HEATER 5705 manufactured by Teleflex Medical.

MAUDE Entry Details

Report Number3011137372-2020-00007
MDR Report Key9555025
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2020-01-06
Date of Report2019-12-19
Date of Event2019-11-19
Date Mfgr Received2020-01-28
Date Added to Maude2020-01-06
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 ContactKATHARINE TARPLEY
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9194334854
Manufacturer G1TELEFLEX MEDICAL
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal Code27560
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHUDSON THERMAGARD NEBULIZER HEATER
Generic NameBREATHING SYSTEM HEATER
Product CodeBZE
Date Received2020-01-06
Returned To Mfg2019-12-30
Catalog Number5705
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressMORRISVILLE NC


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-06

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