MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE SILICONE PILOT BALLOON SIZE 5; AIRWAY, OROPHARYNGEAL, ANESTHE

Catalog Number	105300-000050
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pulmonary Edema (2020)
Date of Event	12/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: "patient was emerging from anesthesia post right ring finger orif.During extubation the patient bit down at the point of connection between the mask and the shaft of the tube.The mask became lodged in the patient's airway causing flash pulmonary edema which required transport and admission to a local hospital for stabilization, patient was discharged 2 days later".
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that: "patient was emerging from anesthesia post right ring finger orif.During extubation the patient bit down at the point of connection between the mask and the shaft of the tube.The mask became lodged in the patient's airway causing flash pulmonary edema which required transport and admission to a local hospital for stabilization, patient was discharged 2 days later".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: LMA UNIQUE SILICONE PILOT BALLOON SIZE 5
• Common Device Name: AIRWAY, OROPHARYNGEAL, ANESTHE
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): THE LARYNGEAL MASK COMPANY (M) SDN. BHD; lot 19 , jalan hi-tech 3; zon industri fasa 1, kulim hi-tech park; kulim kedah 09090 ; MY 09090
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23932471
• Report Number: 3009307931-2025-00047
• Device Sequence Number: 15859765
• Product Code: CAE
• UDI-Device Identifier: 15060112316125
• UDI-Public: (01)15060112316125(11)250305(17)280304(10)11F25B0259(21)
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2025

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 Catalogue Number: 105300-000050
• Device Lot Number: 11F25B0259
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED.; NOT REPORTED.
• Patient Sex: Unknown