AIRFLOW WORK STATION 330TS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-03-02 for AIRFLOW WORK STATION 330TS manufactured by Laminaire Corp..

Event Text Entries

[11522] Laminar flow hood emits pungent odor through filter.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1005293
MDR Report Key20086
Date Received1995-03-02
Date of Report1995-02-15
Date of Event1995-02-15
Date Added to Maude1995-03-03
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 NameAIRFLOW WORK STATION
Generic NameLAMINAR FLOW HOOD
Product CodeFRF
Date Received1995-03-02
Model Number330TS
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key19976
ManufacturerLAMINAIRE CORP.
Manufacturer AddressRAHWAY NJ 070655697 US


Patients

Patient NumberTreatmentOutcomeDate
10 1995-03-02

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