MAUDE Adverse Event Report: AMBU A/S AMBU AURAGAIN SIZE 4

Catalog Number	408400000
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
Traumatic injury with mask removal.During several uses of the mask, the patient had injuries with bleeding when the mask was removed.One patient had a cut on the tongue frenulum and a hematoma, which required an ent check.The mask was used correctly by trained medical staff.The issue has been reported to quality for follow-up and analysis.Patient outcome: unknown.
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 "cut on the tongue frenulum." investigation: neither sample nor pictures are available for investigation, so visual inspection is not performed.According to customer report, the patient had injuries with bleeding when the laryngeal mask was removed.The medical advisor's assessment is as follows: "lingual frenulum tears are a known complication associated with supraglottic airway (sga) devices, typically occurring during the insertion phase.This usually happens when the tongue obstructs the pathway and forceful advancement displaces the tongue posteriorly, leading to frenulum injury.In such cases, the clinician would generally feel resistance during insertion and apply additional force." according to the ifu stated that "do not use excessive force when inserting and removing auragain as this can lead to tissue trauma." additionally, if the product has sharp edges, these could cause throat fissures during insertion.Regarding product appearance, flash/burs are required with no sharp edges, as specified in the ambu injection control procedure.A 100% appearance inspection during production process with ambu work instruction.After reviewing the complaints during the past one year, there have been no complaints tracking product appearance issues to patient injury or bleeding.In this case, no sample was returned, the root cause cannot be identified.The patient was affected, but the patient's condition is unknow after several times confirmation.According to the ifu, any appearance failure should be detectable during the pre-check, and "always have a spare ambu auragain ready for use".The complaint rate of this failure is within the probability of harm of level p1 in the product risk evaluation.This risk has been analyzed and evaluated as acceptable in product risk evaluation.The potential adverse event by using laryngeal mask that has been stated in ifu.Based on the above, no further corrective actions are required at this tim.

• Brand Name: AMBU AURAGAIN SIZE 4
• Common Device Name: AMBU AURAGAIN 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: 25604313
• Report Number: 9610691-2026-00023
• Device Sequence Number: 9914623
• Product Code: CAE
• UDI-Device Identifier: 05707480129577
• UDI-Public: 05707480129577
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,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: 408400000
• Device Lot Number: 1001119216
• 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
• Date Device Manufactured: 01/06/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown