MAUDE Adverse Event Report: AMBU A/S AURAGAIN; LARYNGEAL MASK

Model Number	SIZE 4
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Nerve Damage (1979); Hyporesponsive to stimuli (2683)
Date of Event	05/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As per the customer, sensory deficit of the tip of the tongue after general anesthesia was still persisting 7 days after the procedure.We have no information about patient condition at a later time point; therefore, we cannot rule out that the patient has gotten a permanent impairment.According to the clinical assessment, sensory deficit, or numbness, at the tip of the tongue after general anesthesia is a relatively rare but possible complication, often due to lingual nerve injury.This can be caused by nerve damage or inflammation, possibly due to airway manipulation [incl.The use of laryngeal mask airway such as the aura laryngeal mask] or pressure during the procedure.While most cases resolve within weeks, full recovery can take several weeks or even months, and rare cases of permanent nerve damage have been reported.Postoperative lingual nerve injury is a quite rare complication.A retrospective matched case-control study (doi: 10.1371/journal.Pone.0190589) found that "the overall incidence rate of postoperative lingual neuropraxy [nerve injury] was 0.066% in patients receiving general anesthesia with airway device in place [laryngeal mask as well as endotracheal tube]".It seems like the injury for most of these patients is temporary, and only a small proportion of these suffer permanent injury.Per the instructions for use, nerve injury is listed amongst potential adverse events as a major adverse effect.Considering, it is not product design issue or manufacturing issue, this is the first time to report sensory deficit of the tip of the tongue after general anesthesia on aura gain during past 12 months, there are no further actions at this time.
Event or Problem Description
The customer reported that patient had sensory deficit of the tip of the tongue after ga exam.The deficit was still persisting 7 days after the procedure.

• Brand Name: AURAGAIN
• Common Device Name: LARYNGEAL MASK
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, dnk 2750 ; DA 2750
• MDR Report Key: 22472588
• Report Number: 1220828-2025-00019
• Device Sequence Number: 18118918
• 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: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/10/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SIZE 4
• Device Catalogue Number: 408400000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/16/2025
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/10/2025
• 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: Disability
• Patient Sex: Unknown