SHILEY 5.0PDC

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 2020-03-31 for SHILEY 5.0PDC manufactured by Mmj Sa De Cv (usd).

Event Text Entries

[186019220] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[186019221] According to the reporter, after opening the new product, when performing cuff check, air got out immediately. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2936999-2020-00240
MDR Report Key9908681
Report SourceFOREIGN,USER FACILITY
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-12
Date Mfgr Received2020-03-12
Device Manufacturer Date2018-10-25
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
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 StreetAVE HENEQUEN NO 1181 DESARROLL
Manufacturer CityCIUDAD JUAREZ,MX 32590
Manufacturer CountryMX
Manufacturer Postal Code32590
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 Number5.0PDC
Catalog Number5.0PDC
Lot Number18J0686JZX
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMMJ SA DE CV (USD)
Manufacturer AddressAVE HENEQUEN NO 1181 DESARROLL CIUDAD JUAREZ,MX 32590 MX 32590


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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