BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYGH-TEC BASIC-PLUS

    MDR report key: 24897682 · Received April 16, 2026

    Report

    Report Number
    3015237-2026-00004
    Event Type
    Injury
    Date Received
    April 16, 2026
    Date of Event
    July 23, 2023
    Report Date
    April 16, 2026
    Manufacturer
    ADVANCED MEDICAL BALLOONS GMBH
    Product Code
    KNT
    UDI-DI
    04260566430000
    PMA / PMN Number
    K221400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFFECTED PRODUCT WAS NOT RETURNED FOR EVALUATION. THE FOLLOWING IS LISTED IN THE WARNINGS SECTION OF THE DEVICE'S INSTRUCTIONS FOR USE: "THE FOLLOWING WARNINGS MUST BE TAKEN INTO ACCOUNT WHEN MAKING THE INDICATION FOR THE USE OF THE PRODUCT AND OVER THE COURSE OF THE USE OF THE PRODUCT:· PREVIOUS SURGERY IN THE PATIENT'S COLON, RECTUM OR ANUS IN THE LAST SIX MONTHS MUST BE CLARIFIED BY THE DOCTOR PROVIDING TREATMENT IN TERMS OF THE POSTOPERATIVE CONDITIONS AND POSTOPERATIVE PERFUSION SITUATION BEFORE THE PRODUCT IS USED." THEREFORE, THE ROOT CAUSE OF THE EVENT WAS DETERMINED TO BE A USE OF DEVICE PROBLEM.

    Description of Event or Problem · 0

    REPORT RECEIVED OF A PATIENT EXPERIENCING MASSIVE BLEEDING RELATED TO THE HYGH TEC DEVICE. REPORTEDLY, AND 81-YEAR-OLD ONCOLOGIC MALE PATIENT WHO HAD UNDERGONE BOWEL SURGERY AND HAD A COAGULATION DISORDER HAD A HYGHTEC IN PLACE FOR AN UNKNOWN PERIOD OF TIME. THE PATIENT EXPERIENCED MASSIVE RECTAL BLEEDING AFTER THE DEVICE WAS DISCONTINUED AND HE WAS DISCHARGED. THE PATIENT PRESENTED AGAIN AT THE FACILITY ON (B)(6) 2023, AND A COLONOSCOPY WAS PERFORMED WHICH SHOWED MUCOSAL LESIONS WITH ASSOCIATED BLEEDING THAT WAS CHARACTERIZED AS MASSIVE AND WAS DETERMINED BY THE PHYSICIAN TO HAVE BEEN CAUSED BY THE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463860 HYGH-TEC BASIC-PLUS TUBES, GASTROINTESTINAL KNT ADVANCED MEDICAL BALLOONS GMBH V01-10017 2323012 04260566430000

    Patients

    Seq Age Sex Outcome Treatment
    1