BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYGHTEC BASIC PLUS

    MDR report key: 24317116 · Received February 11, 2026

    Report

    Report Number
    3015237508-2026-00002
    Event Type
    Injury
    Date Received
    February 11, 2026
    Report Date
    February 11, 2026
    Manufacturer
    ADVANCED MEDICAL BALLOONS GMBH
    Product Code
    KNT
    PMA / PMN Number
    K221400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    REPORT RECEIVED OF A PATIENT EXPERIENCING A PRESSURE INJURY WHILE USING THE HYGHTEC BASIC-PLUS DEVICE. REPORTER STATED A PATIENT OF UNKNOWN AGE AND GENDER DEVELOPED SACRAL AND ANAL PRESSURE WOUNDS REQUIRING SURGICAL DEBRIDEMENT WHILE USING THE HYGHTEC BASIC-PLUS DEVICE. THE REPORTER NOTED THAT THE AFFECTED PATIENT WAS MOBILIZED AND POSITIONED IN A CHAIR AT THE TIME THE INJURY DEVELOPED. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377368 HYGHTEC BASIC PLUS TUBES, GASTROINTESTINAL KNT ADVANCED MEDICAL BALLOONS GMBH V01-10017 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention