BALLARD 1500 FLEX HEAT AND MOISTURE EXCHANGER 109381603

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-09-27 for BALLARD 1500 FLEX HEAT AND MOISTURE EXCHANGER 109381603 manufactured by Avanos Medical Inc..

MAUDE Entry Details

Report Number3011270181-2019-00041
MDR Report Key9132101
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-09-27
Date of Report2019-11-27
Date of Event2019-08-30
Date Mfgr Received2019-11-04
Date Added to Maude2019-09-27
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 ContactMS. LISA CLARK
Manufacturer Street5405 WINDWARD PARKWAY
Manufacturer CityALPHARETTA GA 30004
Manufacturer CountryUS
Manufacturer Postal30004
Manufacturer Phone4704485444
Manufacturer G1TRINITY MEDICAL DEVICES INC.
Manufacturer Street1 PLUCKEMIN WAY
Manufacturer CityBEDMINSTER NJ 07921
Manufacturer CountryUS
Manufacturer Postal Code07921
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBALLARD 1500 FLEX HEAT AND MOISTURE EXCHANGER
Generic NameVAP AIRWAY CIRCUIT DRAINS, HME & ACCESSORIES
Product CodeBYD
Date Received2019-09-27
Model Number150
Catalog Number109381603
Lot Number20-1904-158
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerAVANOS MEDICAL INC.
Manufacturer Address5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-27

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