BOURDON FLOWMETER/REGULATOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-06-30 for BOURDON FLOWMETER/REGULATOR manufactured by Mada Medical Products, Inc..

Event Text Entries

[9354] Flowrate decreases as pressure in cylinder decreases. For example, flow at 2000 psi is 4 l/m, and flow at 1000 psi is 3 l/m.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1002651
MDR Report Key14430
Date Received1994-06-30
Date of Report1994-06-13
Date Added to Maude1994-07-01
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameBOURDON FLOWMETER/REGULATOR
Generic NameFLOWMETER/REGULATOR
Product CodeCCN
Date Received1994-06-30
Model NumberNA
Catalog NumberNA
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key14424
ManufacturerMADA MEDICAL PRODUCTS, INC.
Manufacturer AddressCARLSTADT NJ 07072 US


Patients

Patient NumberTreatmentOutcomeDate
10 1994-06-30

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