MAUDE Adverse Event Report: DYNAREX 4595 NASOPHARYNGEAL AIRWAY 28FR

Model Number	28FR
Health Effect - Clinical Codes	Aspiration/Inhalation (1725); Foreign Body In Patient (2687)
Date of Event	04/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Ems report states that a suspected overdose patient aspirated a 28fr nasopharyngeal airway through the nose.It is unclear whether the adverse event was a contributing factor in the patient's later death.

• Brand Name: DYNAREX 4595 NASOPHARYNGEAL AIRWAY 28FR
• Common Device Name: NASOPHARYNGEAL AIRWAY
• MDR Report Key: 11870113
• Report Number: 2431014-2021-00002
• Device Sequence Number: 19107310
• Product Code: BTQ
• UDI-Device Identifier: 00840117315419
• UDI-Public: 840117315419
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/24/2021
• Report Date (Section F): 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/15/2022
• Device Model Number: 28FR
• Device Catalogue Number: 4595
• Device Lot Number: 39770
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 2 YR
• Event Location: Home
• Date Report to Manufacturer: 05/14/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 25 YR
• Patient Weight: 60
• Date Report Sent to FDA: 05/19/2021