ARNDT ENDOBRONCHIAL BLOCKER SET UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-06-08 for ARNDT ENDOBRONCHIAL BLOCKER SET UNKNOWN manufactured by Cook Inc.

Event Text Entries

[110507825] Based on device name physician reported. (b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10


[110507826] A physician reported to a cook representative during a conference he had received a batch of arndt endobronchial blocker balloons that collapsed after less than 12 hours in use. As reported, one patient was said not to survive and is represented in this report. The physician stated the a patient passed but it was not due to the device's performance. Medwatch 1820334-2018-01678 and medwatch 1820334-2018-01677 are being reported as device malfunctions with no patient harm. To date, additional information is unable to be provided by the reporting physician.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1820334-2018-01676
MDR Report Key7582842
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2018-06-08
Date of Report2018-09-19
Date of Event2017-11-10
Date Mfgr Received2018-08-20
Date Added to Maude2018-06-08
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 ContactMR. LARRY POOL
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal47404
Manufacturer Phone8123392235
Manufacturer G1COOK INC
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal Code47404
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameARNDT ENDOBRONCHIAL BLOCKER SET
Generic NameBWC NEEDLE, EMERGENCY AIRWAY
Product CodeBWC
Date Received2018-06-08
Catalog NumberUNKNOWN
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOOK INC
Manufacturer Address750 DANIELS WAY BLOOMINGTON IN 47404 US 47404


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2018-06-08

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