BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYGHTEC BASIC PLUS

    MDR report key: 24317115 · Received February 11, 2026

    Report

    Report Number
    3015237508-2026-00001
    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

    Additional Manufacturer Narrative · 0

    THE AFFECTED PRODUCT WAS NOT RETURNED FOR EVALUATION. A TOTAL OF NINETEEN BATCHES WERE DELIVERED TO CHARITÉ BERLIN BETWEEN MAY 2024 AND JANUARY 2026. A DESIGN HISTORY REVIEW WAS COMPLETED FOR THE BATCHES 2438001, 2443001, 2445016, 2447003, 2501002, 250201, 250600, 2514003, 2516008, 2520007, 2530004, 2532004, 253800, 254400, 2546015, 2550002, AND 2551003 OF FINISHED GOOD V01-10017. NO FAILED PROCESS CONTROLS OR MANUFACTURING PROBLEMS WERE IDENTIFIED. A LABELING REVIEW WAS CONDUCTED AND DETERMINED THAT THERE NOT ADEQUATE INSTRUCTION FOR USE OF THE PRODUCT MOBILIZED PATIENTS, SPECIFICALLY IN SEATED POSITIONS. THE ROOT CAUSE WAS DETERMINED TO BE INADEQUATE LABELING AND/OR INSTRUCTIONS FOR USE.

    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
    380822 HYGHTEC BASIC PLUS TUBES, GASTROINTESTINAL KNT ADVANCED MEDICAL BALLOONS GMBH V01-10017 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention