MAUDE Adverse Event Report: TELEFLEX INCORPORATED LMA ATOMIZATION; NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)

Model Number	IPN049182
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Intranasal mucosal atomization device not working properly.When in use, it sprays a stream rather than atomizing.

• Brand Name: LMA ATOMIZATION
• Common Device Name: NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 17860581
• Report Number: 17860581
• Device Sequence Number: 5692908
• Product Code: CCQ
• UDI-Device Identifier: 14026704626547
• UDI-Public: (01)14026704626547
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/27/2023
• Report Date (Section F): 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: IPN049182
• Device Catalogue Number: MAD300
• Device Lot Number: 73G2200372
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/03/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/27/2023