MAUDE Adverse Event Report: AMBU A/S AMBU AURASTRAIGHT U SIZE 4

Catalog Number	324400000U
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint has been re-evaluated as part of a corrective action related to an observation on risk management identified during an fda inspection.H6 - heath effect code: no code available for "cutting patient's throat" investigation: neither sample nor picture was available for investigation, visual inspection was not performed.Per the customer reported failure, "the product cutting patient's throats", may be caused by excessive force during insertion or by sharp edges on the product.The patient was involved, but their condition is unknown.Due to limited information, the root cause cannot be determined.No corrective actions will be taken at this time.
Event or Problem Description
We have been receiving a lot of provider complaints about the lma's cutting patient's throats.Specifically the 3244.

• Brand Name: AMBU AURASTRAIGHT U SIZE 4
• Common Device Name: AMBU AURASTRAIGHT U SIZE 4
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, dnk 2750 ; DA 2750
• MDR Report Key: 25611541
• Report Number: 1220828-2026-00021
• Device Sequence Number: 5405842
• Product Code: CAE
• UDI-Device Identifier: 05707480037537
• UDI-Public: 05707480037537
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 06/24/2026
• Report Date (Section F): 06/24/2026

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: 324400000U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/09/2026
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 06/24/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown