FDA.reportPublic FDA data

MAUDE MDR 8101256

MDR report key
8101256
Report number
8101256
Event key
0
Event type
3
Date of event
2018-10-16
Date received
2018-11-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
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
1TUBE, ENDOTRACHEALMEDTRONIC XOMED, INC.LNZUNKUNKUNK* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-11-260

Event Narratives#

D

Patient 1

DURING PROCEDURE START, POST INTUBATION, OXYGEN SATURATIONS DECREASED BRIEFLY. TROUBLESHOOTING DONE. ADDITIONAL SUPPORT GIVEN AND OXYGEN LEVEL RETURNED THROUGHOUT PROCEDURE. UPON EXTUBATION, THE BALLOON ON ENDOTRACHEAL TUBE (ETT) WAS MALFORMED.