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
Event or Problem Description
The customer reported that patient had sensory deficit of the tip of the tongue after general anesthesia (ga) exam.The deficit was still persisting 7 days after the procedure.
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 no product design issue or manufacturing issue, this is a first time to report sensory deficit of the tip of the tongue after general anesthesia on aura gain during past 12 months, the complaint rate of 0.43cppm which is within the probability level p1, therefore, there are no further actions at this time.

• Brand Name: AURAGAIN
• Common Device Name: LARYNGEAL MASK
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, 2750 ; DA 2750
• Manufacturer (Section G): AMBU LTD.; warehouse & process complex; building, no.c xiang yu ftz.; xiamen, fujian 36100 6; CH 361006
• Manufacturer Contact: lenka vaculciakova ; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 22466848
• Report Number: 9610691-2025-00019
• Device Sequence Number: 7986140
• Product Code: BTO
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• 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?: No
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 07/10/2025
• 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: Disability
• Patient Sex: Unknown