BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYGH-TEC BASIC-PLUS

    MDR report key: 25338628 · Received May 29, 2026

    Report

    Report Number
    3015237508-2026-00004
    Event Type
    Injury
    Date Received
    May 29, 2026
    Date of Event
    July 23, 2023
    Report Date
    May 29, 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. REVIEW OF THE DEVICE INSTRUCTIONS FOR USE (IFU) IDENTIFIED THAT THE DEVICE IS CONTRAINDICATED FOR USE IN PATIENTS WITH UNCLEAR OR DIAGNOSTICALLY UNCLARIFIED RECTAL OR ANAL BLEEDING, ACCUMULATIONS OF BLOOD IN THE STOOL, AND IN PATIENTS WHO HAVE UNDERGONE SURGERY OF THE COLON, RECTUM, OR ANUS WITHIN THE PREVIOUS SIX MONTHS. BASED ON THE AVAILABLE INFORMATION AND IFU REVIEW, THE EVENT WAS DETERMINED TO BE ASSOCIATED WITH USE OF THE DEVICE IN THE PRESENCE OF A CONTRAINDICATED CONDITION. THE ROOT CAUSE WAS THEREFORE CLASSIFIED AS USE OF DEVICE PROBLEM. THIS REPORT REPLACES REPORT, WHICH CONTAINED AN ERRONEOUS FACILITY ESTABLISHMENT IDENTIFIER (FEI) WITHIN THE MANUFACTURER REPORT NUMBER AND WAS SUBSEQUENTLY REQUESTED TO BE WITHDRAWN. THE LATE SUBMISSION OF THIS REPORT WAS DUE TO AMB'S COMPLAINT HANDLING AND VIGILANCE PROCEDURES, REPORTABILITY DETERMINATION METHODOLOGY, AND PERSONNEL TRAINING. THIS REPORT IS BEING SUBMITTED FOLLOWING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED UNDER (B)(4) AFTER STRYKER ACQUISITION OF ADVANCED MEDICAL BALLOONS GMBH (AMB) . STRYKER OPENED CAPA 4343509 TO ADDRESS THE PROCEDURAL FINDINGS IN (B)(4).

    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
    202000 HYGH-TEC BASIC-PLUS TUBES, GASTROINTESTINAL KNT ADVANCED MEDICAL BALLOONS GMBH V01-10017 2323012 04260566430000

    Patients

    Seq Age Sex Outcome Treatment
    1