SHILEY 8PERC

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-10 for SHILEY 8PERC manufactured by Covidien Ag Juarez (mmj).

Event Text Entries

[178362582] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[178362583] According to the reporter, the first item balloon was broken or damaged and the 2nd item balloon did not inflate. There was no allegation of patient death or serious injury associated with this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2936999-2020-00105
MDR Report Key9686941
Report SourceUSER FACILITY
Date Received2020-02-10
Date of Report2020-03-09
Date of Event2020-01-01
Date Mfgr Received2020-01-24
Date Added to Maude2020-02-10
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 G1COVIDIEN AG JUAREZ (MMJ)
Manufacturer Street1181 HENNEQUEN AVE.
Manufacturer CityJUAREZ,CHI 32575
Manufacturer CountryMX
Manufacturer Postal Code32575
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSHILEY
Generic NameTUBE, TRACHEOSTOMY (W/WO CONNECTOR)
Product CodeBTO
Date Received2020-02-10
Model Number8PERC
Catalog Number8PERC
Lot Number19D0646JZX
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN AG JUAREZ (MMJ)
Manufacturer Address1181 HENNEQUEN AVE. JUAREZ,CHI 32575 MX 32575


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-10

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