SMITHS MEDICAL TRACHEOSTOMY TUBE HOLDER 100/503/200

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-10-08 for SMITHS MEDICAL TRACHEOSTOMY TUBE HOLDER 100/503/200 manufactured by Smiths Medical Asd, Inc..

MAUDE Entry Details

Report Number3012307300-2019-05531
MDR Report Key9168549
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2019-10-08
Date of Report2019-10-08
Date of Event2019-09-30
Date Mfgr Received2019-10-03
Date Added to Maude2019-10-08
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPHARMACIST
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, CT216JL
Manufacturer CountryUK
Manufacturer Postal CodeCT21 6JL
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSMITHS MEDICAL TRACHEOSTOMY TUBE HOLDER
Generic NameSUPPORT, BREATHING TUBE
Product CodeJAY
Date Received2019-10-08
Catalog Number100/503/200
Lot Number023411
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD, INC.
Manufacturer Address6000 NATHAN LANE N MINNEAPOLIS MN 55442 US 55442


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-08

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