SHILEY 18875

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 2020-03-16 for SHILEY 18875 manufactured by Mmj Sa De Cv (usd).

Event Text Entries

[183527764] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[183527765] According to the reporter, during use, there was an airflow sound. Upon checking, there was a balloon air leakage. Re-intubation required.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2936999-2020-00206
MDR Report Key9835499
Report SourceFOREIGN,USER FACILITY
Date Received2020-03-16
Date of Report2020-03-16
Date of Event2019-12-09
Date Mfgr Received2020-02-28
Device Manufacturer Date2018-11-07
Date Added to Maude2020-03-16
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 32590
Manufacturer CountryMX
Manufacturer Postal Code32590
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSHILEY
Generic NameTUBE, TRACHEAL (W/WO CONNECTOR)
Product CodeBTR
Date Received2020-03-16
Model Number18875
Catalog Number18875
Lot Number18K0112JZX
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 32590 MX 32590


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-16

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