FDA.reportPublic FDA data

MAUDE MDR 6692311

MDR report key
6692311
Report number
6692311
Event key
0
Event type
3
Date of event
2017-06-14
Date received
2017-07-07
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
1EZ-SPRAY ATOMIZERNEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)ALCOVE MEDICAL INC.CCQEZ-103AEZ-103ANO LOT IDENTIFIEDR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-07-070

Event Narratives#

N

Patient 1

D

Patient 1

PHYSICIAN WAS TROPICALIZING PATIENT'S OROPHARYNX FOR AWAKE INTUBATION WHEN THE NOZZLE OF THE EZ-SPRAY DEVICE BROKE OFF INTO PATIENT'S MOUTH. THE PATIENT WAS ABLE TO STOP THE PARTS WITH HIS TONGUE AND SPIT THE COMPONENTS OUT. THE COMPONENTS WERE A SPRING AND PUSH ROD. NO HARM TO PATIENT.