AERONOX 2.0 731-9159 IP33

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-23 for AERONOX 2.0 731-9159 IP33 manufactured by International Biomedical Ltd..

MAUDE Entry Details

Report NumberMW5089979
MDR Report Key9106492
Date Received2019-09-23
Date of Report2019-09-19
Date of Event2019-09-04
Date Added to Maude2019-09-23
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 1

Brand NameAERONOX 2.0
Generic NameAPPARATUS, NITRIC OXIDE
Product CodeMRN
Date Received2019-09-23
Model Number731-9159 IP33
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerINTERNATIONAL BIOMEDICAL LTD.
Manufacturer AddressAUSTIN TX US

Device Sequence Number: 2

Brand NameAERONOX 2.0
Generic NameAPPARATUS, NITRIC OXIDE
Product CodeMRN
Date Received2019-09-23
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No2
Device Event Key0
ManufacturerINTERNATIONAL BIOMEDICAL LTD.

Device Sequence Number: 3

Brand NameAERONOX 2.0
Generic NameAPPARATUS, NITRIC OXIDE
Product CodeMRN
Date Received2019-09-23
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No3
Device Event Key0
ManufacturerINTERNATIONAL BIOMEDICAL LTD.


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-23

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