BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYGHTEC BASIC PLUS

    MDR report key: 25338434 · Received May 29, 2026

    Report

    Report Number
    3015237508-2026-00003
    Event Type
    Injury
    Date Received
    May 29, 2026
    Date of Event
    September 3, 2025
    Report Date
    May 29, 2026
    Manufacturer
    ADVANCED MEDICAL BALLOONS GMBH
    Product Code
    KNT
    PMA / PMN Number
    K221400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED.NEITHER LOT INFORMATION NOR DEVICE USAGE DETAILS WERE PROVIDED.BASED ON THE AVAILABLE INFORMATION, NO EVIDENCE OF A PRODUCT DEFECT, MALFUNCTION, OR MANUFACTURING-RELATED ISSUE WAS ABLE TO BE CONFIRMED.POTENTIAL ROOT CAUSES FOR THE REPORTED COMPLAINT ARE INCORRECT INDICATION / INDIVIDUAL CASE ASSESSMENT OR INCORRECT / TOO LARGE FILLING VOLUME, HOWEVER WITHOUT ADDITIONAL INFORMATION, THE DEFINITIVE ROOT CAUSE COULD NOT BE CONFIRMED.THEREFORE, THE INVESTIGATION REVEALED THAT A ROOT CAUSE COULD NOT BE ESTABLISHED FOR THE REPORTED COMPLAINT.COMPLAINTS REGARDING RECTAL RESECTION FOR THE HYGHTEC DRAINAGE SYSTEM WILL CONTINUE TO BE MONITORED AND TRENDED. 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FACILITY ESTABLISHMENT IDENTIFIER (FEI) WITHIN THE MANUFACTURER REPORT NUMBER AND WAS SUBSEQUENTLY REQUESTED TO BE WITHDRAWN.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

    IT WAS NOTED WITHIN A CUSTOMER'S PROFILE WITHIN THE CRM DATABASE, THAT A PATIENT WITH VASCULAR COMPROMISE HAD A HYGH-TEC DEVICE PLACED AT AN UNKNOWN POINT IN THEIR TREATMENT. THE PATIENT UNDERWENT A RECTAL RESECTION AT AN UNKNOWN POINT IN THEIR TREATMENT AND FOR AN UNKNOWN CAUSE. INFORMATION WAS RECEIVED RELATED TO THIS REPORT THAT STOOL DRAINAGE DEVICES WERE BANNED FROM USE IN PATIENTS WITH VASCULAR COMPROMISE IN THE FUTURE. ALTHOUGH THE REASON FOR RECTAL RESECTION IS NOT CLEAR, THE RECEIPT OF INFORMATION RELATED TO THIS COMPLAINT, THAT THE USE OF STOOL DRAINAGE SYSTEMS WAS BANNED, REASONABLY SUGGESTS THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO PATIENT REQUIRING A RECTAL RESECTION. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521150 HYGHTEC BASIC PLUS TUBES, GASTROINTESTINAL KNT ADVANCED MEDICAL BALLOONS GMBH V01-10017 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1