INOVENT, NITRIC OXIDE DELIVERY SYSTEM 1605-9200-000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-11 for INOVENT, NITRIC OXIDE DELIVERY SYSTEM 1605-9200-000 manufactured by Mallinckrodt Manufacturing Llc..

MAUDE Entry Details

Report Number3004531588-2020-00028
MDR Report Key9821381
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-11
Date of Report2020-03-11
Date of Event2019-12-14
Date Mfgr Received2019-12-14
Device Manufacturer Date2006-02-10
Date Added to Maude2020-03-11
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 ContactMEGAN VERNAK
Manufacturer Street1425 US ROUTE 206
Manufacturer CityBEDMINSTER NJ 07921
Manufacturer CountryUS
Manufacturer Postal07921
Manufacturer G1MALLINCKRODT MANUFACTURING LLC.
Manufacturer Street6603 FEMRITE DRIVE
Manufacturer CityMADISON WI 53718
Manufacturer CountryUS
Manufacturer Postal Code53718
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINOVENT, NITRIC OXIDE DELIVERY SYSTEM
Generic NameAPPRATUS, NITRIC OXIDE DELIVERY
Product CodeMRN
Date Received2020-03-11
Returned To Mfg2019-12-26
Model Number1605-9200-000
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMALLINCKRODT MANUFACTURING LLC.
Manufacturer AddressMADISON WI US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-11

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