BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENIO 2.1 SYSTEM

    MDR report key: 25237450 · Received May 20, 2026

    Report

    Report Number
    3017191859-2026-00016
    Event Type
    Injury
    Date Received
    May 20, 2026
    Date of Event
    April 21, 2026
    Report Date
    May 20, 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

    Description of Event or Problem · 0

    DURING A ROUTINE VISIT TO THE CLINIC, THE SURGEON REPORTED THAT THE PATIENT HAD BEEN SEEN AT THE HOSPITAL DUE TO DELAYED WOUND HEALING FOLLOWING SURGERY. HOWEVER, NO SIGNS OF INFLAMMATION WERE NOTED AT THE TIME OF SUTURE REMOVAL. FURTHERMORE, THE PATIENT IS KNOWN TO BE HIV-POSITIVE. THEREFORE, THE DELAYED HEALING PROCESS WAS NOT CONSIDERED UNEXPECTED BY THE SURGEON, WHO PRESCRIBED SPECIALIZED WOUND DRESSINGS ACCORDINGLY. ACTIVATION WILL BE POSTPONED UNTIL COMPLETE WOUND HEALING HAS BEEN ACHIEVED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314372 GENIO 2.1 SYSTEM GENIO 2.1 SYSTEM MNQ NYXOAH S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1