BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AURAGAIN

    MDR report key: 22466848 · Received July 10, 2025

    Report

    Report Number
    9610691-2025-00019
    Event Type
    Injury
    Date Received
    July 10, 2025
    Date of Event
    May 27, 2025
    Report Date
    July 10, 2025
    Manufacturer
    AMBU A/S
    Product Code
    BTO
    UDI-DI
    05707480129577
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1601906 AURAGAIN LARYNGEAL MASK BTO AMBU A/S SIZE 4 05707480129577

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Disability