ACCUTRON *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-11-19 for ACCUTRON * manufactured by Accutron.

Event Text Entries

[252379] An incident occurred in the office with a n2o-o2 unit that was recently installed. The pipes were crossed in the walls. Dentist was giving patients 100% n2o when they thought they were giving them 100% o2. The problem was compounded by the use of a flavored mask. The scent interfered with the characteristic odor of n2o. Dentist could not smell the odor of n2o. They could only smell the scent from the flavored mask.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1026863
MDR Report Key430489
Date Received2002-12-02
Date of Report2002-11-19
Date of Event2002-10-01
Date Added to Maude2002-12-04
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameACCUTRON
Generic NameNASAL HOOD WITH SCENTS
Product CodeKHA
Date Received2002-11-19
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key419461
ManufacturerACCUTRON
Manufacturer Address1733 WEST PARKSIDE LANE PHOENEX AZ 85027 US


Patients

Patient NumberTreatmentOutcomeDate
10 2002-12-02

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