COVIDIEN SHILEY #6 CFN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-07 for COVIDIEN SHILEY #6 CFN manufactured by Covidien.

MAUDE Entry Details

Report NumberMW5088889
MDR Report Key8874266
Date Received2019-08-07
Date of Report2019-07-31
Date of Event2019-07-29
Date Added to Maude2019-08-08
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
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: 0

Brand NameCOVIDIEN SHILEY #6 CFN
Generic NameTUBE, TRACHEOSTOMY (W/WO CONNECTION)
Product CodeBTO
Date Received2019-08-07
Lot Number18K0582JZX
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No0
Device Event Key0
ManufacturerCOVIDIEN

Device Sequence Number: 1

Brand NameCOVIDIEN SHILEY #6 CFN
Generic NameTUBE, TRACHEOSTOMY (W/WO CONNECTION)
Product CodeBTO
Date Received2019-08-07
Lot Number18K0582JZX
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN SHILEY

Device Sequence Number: 2

Brand NameCOVIDIEN SHILEY #6 CFN
Generic NameTUBE, TRACHEOSTOMY (W/WO CONNECTION)
Product CodeBTO
Date Received2019-08-07
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No2
Device Event Key0
ManufacturerCOVIDIEN SHILEY


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-08-07

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