MAUDE Adverse Event Report: Teleflex Medical MADGIC ATOMIZER WITHOUT SYRINGE; APPLICATOR (LARYNGO-TRACHEAL),

Catalog Number	MAD700
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as the sample has not been returned for analysis.A device history record review was performed, and there were no relevant findings.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

• Brand Name: MADGIC ATOMIZER WITHOUT SYRINGE
• Common Device Name: APPLICATOR (LARYNGO-TRACHEAL),
• Manufacturer (Section D): Teleflex Medical; morrisville NC
• Manufacturer (Section G): Teleflex Medical; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: marling heaton ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 50173122
• Report Number: 3003898360-2026-00378
• Device Sequence Number: 8263075
• Product Code: CCT
• UDI-Device Identifier: 14026704709882
• UDI-Public: (01)14026704709882(11)251209(17)281208(10)73L2500896
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K153470
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 07/09/2026

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: MAD700
• Device Lot Number: 73L2500896
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2025
• 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: None reported
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown