MAUDE Adverse Event Report: ALCOVE MEDICAL INC. EZ-SPRAY ATOMIZER; NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)

Model Number EZ-103A

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/14/2017

Event Type  malfunction  

Event Description

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.

• Brand Name: EZ-SPRAY ATOMIZER
• Type of Device: NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)
• Manufacturer (Section D): ALCOVE MEDICAL INC.; 3905 e barton creek dr; eagle mountain 84005
• MDR Report Key: 6692311
• MDR Text Key: 79949139
• Report Number: 6692311
• Device Sequence Number: 1
• Product Code: CCQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: EZ-103A
• Device Catalogue Number: EZ-103A
• Device Lot Number: NO LOT IDENTIFIED
• Other Device ID Number: A9999
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/29/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1