SHILEY 6CFS

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 2020-03-31 for SHILEY 6CFS manufactured by Mmj Sa De Cv (usd).

Event Text Entries

[186019012] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[186019013] According to the reporter, the device inner cannula was tight ad difficult to lock and unlock to outer cannula. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2936999-2020-00241
MDR Report Key9908823
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-13
Date Mfgr Received2020-03-13
Date Added to Maude2020-03-31
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 G1MMJ SA DE CV (USD)
Manufacturer Street9560 JOSE RODRIGUEZ DRIVE
Manufacturer CityEL PASO TX 79927
Manufacturer CountryUS
Manufacturer Postal Code79927
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSHILEY
Generic NameTUBE TRACHEOSTOMY AND TUBE CUFF
Product CodeJOH
Date Received2020-03-31
Model Number6CFS
Catalog Number6CFS
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMMJ SA DE CV (USD)
Manufacturer Address9560 JOSE RODRIGUEZ DRIVE EL PASO TX 79927 US 79927


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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