SHILEY 126035

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-09-06 for SHILEY 126035 manufactured by Mallinckrodt Medical.

MAUDE Entry Details

Report Number8020889-2019-00111
MDR Report Key8972905
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-09-06
Date of Report2019-09-06
Date of Event2019-08-14
Date Mfgr Received2019-08-14
Device Manufacturer Date2019-01-23
Date Added to Maude2019-09-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactAVI KLUGER
Manufacturer Street5920 LONGBOW DRIVE
Manufacturer CityBOULDER CO 80301
Manufacturer CountryUS
Manufacturer Postal80301
Manufacturer Phone3035306582
Manufacturer G1MALLINCKRODT MEDICAL
Manufacturer StreetCORNAMADDY
Manufacturer CityATHLONE 3810
Manufacturer Postal Code3810
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSHILEY
Generic NameTUBE, BRONCHIAL (W/WO CONNECTOR)
Product CodeBTS
Date Received2019-09-06
Model Number126035
Catalog Number126035
Lot Number201811049X
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMALLINCKRODT MEDICAL
Manufacturer AddressCORNAMADDY ATHLONE 3810 3810


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-06

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.