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 for investigation, visual inspection is not performed, the customer reported failure cannot be verified.Per the customer reported that the product cutting patient's throats, it may be caused by the excessive force during insertion or may be caused by sharp edges on the product.Due to limited information, the root cause cannot be defined.The patient was involved, but the patient condition is unknown, the complaint rate is low.Due to the root cause that cannot be defined as limited information, the correct action will not be taken at this time.Since the root cause cannot be identified, there is no additional action is not required at this moment.
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, 2750 ; DA 2750
• Manufacturer (Section G): AMBU LIMITED; no. c, warehouse & process; complex building xiang yu ft.z; xiamen, fujian province, chn 36100 6,,; CH 361006,,
• Manufacturer Contact: catharina engelhardt ; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 25603752
• Report Number: 9610691-2026-00021
• Device Sequence Number: 12101822
• Product Code: CAE
• UDI-Device Identifier: 05707480037537
• UDI-Public: 05707480037537
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown