SHILEY 125028

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 2019-11-15 for SHILEY 125028 manufactured by Mallinckrodt Medical.

MAUDE Entry Details

Report Number8020889-2019-00161
MDR Report Key9329639
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2019-11-15
Date of Report2019-11-15
Date of Event2019-09-02
Date Mfgr Received2019-09-02
Device Manufacturer Date2017-06-02
Date Added to Maude2019-11-15
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 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 Received2019-11-15
Returned To Mfg2019-11-05
Model Number125028
Catalog Number125028
Lot Number201706036X
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMALLINCKRODT MEDICAL
Manufacturer AddressCORNAMADDY ATHLONE 3810 3810


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-15

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