SMITHS MEDICAL UNIPERC ADJUSTABLE FLANGE TRACHEOSTOMY 100/897/070

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2019-11-18 for SMITHS MEDICAL UNIPERC ADJUSTABLE FLANGE TRACHEOSTOMY 100/897/070 manufactured by Smiths Medical Asd, Inc..

MAUDE Entry Details

Report Number3012307300-2019-06246
MDR Report Key9336970
Report SourceFOREIGN,USER FACILITY
Date Received2019-11-18
Date of Report2019-11-18
Date of Event2019-07-11
Date Mfgr Received2019-11-11
Date Added to Maude2019-11-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactDAVE HALVERSON
Manufacturer Street6000 NATHAN LANE N
Manufacturer CityMINNEAPOLIS MN 55442
Manufacturer CountryUS
Manufacturer Postal55442
Manufacturer G1SMITHS MEDICAL INTERNATIONAL LTD.
Manufacturer StreetBOUNDARY ROAD,
Manufacturer CityHYTHE, KENT CT216JL
Manufacturer CountryUK
Manufacturer Postal CodeCT216JL
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSMITHS MEDICAL UNIPERC ADJUSTABLE FLANGE TRACHEOSTOMY
Generic NameTUBE, TRACHEOSTOMY (W/WO CONNECTOR)
Product CodeBTO
Date Received2019-11-18
Catalog Number100/897/070
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD, INC.
Manufacturer Address6000 NATHAN LANE N MINNEAPOLIS MN 55442 US 55442


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-11-18

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