FDA.reportPublic FDA data

MAUDE MDR 7107922

MDR report key
7107922
Report number
7107922
Event key
0
Event type
3
Date of event
2017-09-28
Date received
2017-12-12
Adverse event
0
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NIM CONTACTSTIMULATOR, NERVEMEDTRONIC XOMED, INC.BXN822950882295080210050657R *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-12-120

Event Narratives#

N

Patient 1

D

Patient 1

PATIENT WAS BROUGHT TO THE OPERATING ROOM AND READIED FOR INTUBATION. PATIENT WAS INTUBATED BY DOCTOR USING THE NIM CONTACT EMG ENDOTRACHEAL TUBE (ETT) SIZE 8 WITHOUT PROBLEM. WHEN THE DOCTOR WENT TO INFLATE THE ETT CUFF, THE INFLATION TUBING CAME OFF IN HIS HAND AND HE WAS UNABLE TO INFLATE THE CUFF. THE DOCTOR THEN UTILIZED AN INTRODUCER (BOUGIE) AND REMOVED THE DEFECTIVE ETT, AND REPLACED IT WITH ANOTHER NIM CONTACT EMG ETT SIZE 8. THE CUFF WAS EASILY INFLATED AND THE CASE PROCEEDED WITHOUT FURTHER PROBLEM.