BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENIO IS

    MDR report key: 24472731 · Received February 27, 2026

    Report

    Report Number
    3017191859-2026-00004
    Event Type
    Injury
    Date Received
    February 27, 2026
    Date of Event
    February 5, 2026
    Report Date
    February 23, 2026
    Manufacturer
    NYXOAH S.A.
    Product Code
    MNQ
    PMA / PMN Number
    P240024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE TO SECTION B5 AND D4. AS OF THE SATE OF THE SUBMISSION OF THIS REPORT, THE DEVICE HAS NOT YET BEEN RECEIVED FOR INVESTIGATION.

    Description of Event or Problem · 0

    NYXOAH WAS INFORMED BY THE TREATING PHYSICIAN THAT THE PATIENT REQUIRED A MEDICAL INTERVENTION TO TREAT THE DEVELOPMENT OF A POSTOPERATIVE SUBCUTANEOUS HEMATOMA LOCATED ANTERIOR TO THE MYLOHYOID MUSCLE. SUBCUTANEOUS MEANS THE HEMATOMA WAS LOCATED DIRECTLY UNDER THE SKIN AND NOT BENEATH THE MUSCLE LAYERS. FOR THIS REASON, IT WAS NOT NECESSARY TO OPEN THE MYLOHYOID MUSCLE WHICH IS WHERE THE IMPLANTABLE STIMULATOR (IS) IS LOCATED. NO BLEEDING OCCURRED AT THE IMPLANT SITE. THE EXACT SIZE OF THE HEMATOMA IS UNKNOWN, BUT IT INVOLVED THE SUBMENTAL AREA AND THE SKIN SHOWED PETECHIAE. THE SURGEON ACCESSED THE AREA AND ASPIRATED THE BLOOD THAT HAD COLLECTED DURING WHICH HE CHECKED TO SEE IF THERE WAS ONGOING BLEEDING WHICH THERE WAS NOT. THE ASPIRATION WAS COMPLETED WITHIN A FEW MINUTES AND ACTIVATION OF THE PATIENT WILL BE DELAYED SEVERAL WEEKS TO ALLOW ADEQUATE HEALING.

    Description of Event or Problem · 0

    NYXOAH WAS INFORMED BY THE TREATING PHYSICIAN THAT THE PATIENT REQUIRED A MEDICAL INTERVENTION TO TREAT THE DEVELOPMENT OF A POSTOPERATIVE SUBCUTANEOUS HEMATOMA LOCATED ANTERIOR TO THE MYLOHYOID MUSCLE. SUBCUTANEOUS MEANS THE HEMATOMA WAS LOCATED DIRECTLY UNDER THE SKIN AND NOT BENEATH THE MUSCLE LAYERS. FOR THIS REASON, IT WAS NOT NECESSARY TO OPEN THE MYLOHYOID MUSCLE WHICH IS WHERE THE IMPLANTABLE STIMULATOR (IS) IS LOCATED. NO BLEEDING OCCURRED AT THE IMPLANT SITE. THE EXACT SIZE OF THE HEMATOMA IS UNKNOWN, BUT IT INVOLVED THE SUBMENTAL AREA AND THE SKIN SHOWED PETECHIAE. THE SURGEON ACCESSED THE AREA AND ASPIRATED THE BLOOD THAT HAD COLLECTED DURING WHICH HE CHECKED TO SEE IF THERE WAS ONGOING BLEEDING WHICH THERE WAS NOT. THE ASPIRATION WAS COMPLETED WITHIN A FEW MINUTES AND ACTIVATION OF THE PATIENT WILL BE DELAYED SEVERAL WEEKS TO ALLOW ADEQUATE HEALING. IT IS IMPORTANT TO NOTE THE IMPLANTABLE DEVICE IN THIS COMPLAINT FILE IS NOT DISTRIBUTED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531274 GENIO IS GENIO IS MNQ NYXOAH S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention