BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYGH-TEC

    MDR report key: 24161326 · Received January 23, 2026

    Report

    Report Number
    3015237508-2025-01027
    Event Type
    Injury
    Date Received
    January 23, 2026
    Date of Event
    September 1, 2025
    Report Date
    October 27, 2025
    Manufacturer
    ADVANCED MEDICAL BALLOONS GMBH
    Product Code
    KNT
    UDI-DI
    04260566430116
    PMA / PMN Number
    K221400
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE WAS NOT RETURNED BY THE USER FACILITY FOR EVALUATION. FOR THE AFFECTED BATCH 2414001 (PRODUCTION DATE: 04/02/2024; EXPIRY DATE: 04/02/2026), A BATCH RECORD REVIEW WAS CONDUCTED. NO DEVIATIONS, NONCONFORMITIES, OR ANOMALIES RELATED TO MANUFACTURING, PACKAGING, OR RELEASE WERE IDENTIFIED. ALTHOUGH THE INITIAL REPORTER INDICATED AN EXPIRATION DATE OF 09/01/2025, REVIEW OF THE BATCH RECORDS CONFIRMED THAT THE CORRECT EXPIRATION DATE FOR BATCH 2414001 IS 04/02/2026. IN ADDITION, AN EVALUATION OF POST MARKET DATA CONFIRMED THAT NO FURTHER COMPLAINTS WERE RECEIVED FOR BATCH 2414001. BASED ON THE BATCH RECORD REVIEW AND THE ABSENCE OF ADDITIONAL COMPLAINTS, THERE ARE NO INDICATIONS THAT THE PRODUCT WAS DEFECTIVE OR FAILED TO MEET SPECIFICATIONS.

    Description of Event or Problem · 0

    ON 27-OCT-2025, THE MANUFACTURER RECEIVED A VOLUNTARY FDA FORM 3500 SUBMITTED BY THE REPORTER. ACCORDING TO THE INFORMATION PROVIDED, THE PATIENT HAD A FECAL MANAGEMENT SYSTEM (FMS) IN PLACE. THE INITIAL SYSTEM WAS PLACED ON [REDACTED] AND REMOVED FOUR DAYS LATER. A NEW FMS WAS PLACED ON THE SAME DAY AND REMOVED ON [REDACTED], TWO DAYS LATER, DUE TO REPORTED BALLOON AIR LEAKAGE AND SYSTEM LEAKAGE. UPON REMOVAL, THE PATIENT WAS NOTED TO HAVE A PRESSURE INJURY ON THE RECTUM, WHICH THE REPORTER BELIEVED TO BE ASSOCIATED WITH THE HARD PLASTIC COMPONENT OF THE FMS. THE REPORTER WAS CONTACTED AND PROVIDED THE FOLLOWING DETAILS: NO MEDICAL INTERVENTION WAS NEEDED OTHER THAN WOUND CARE. SKIN AFFECTED, PT REPORTED 10/10 PAIN LEVEL. ADDITIONAL ATTEMPTS WERE MADE TO OBTAIN FURTHER DETAILS INCLUDING CLARIFICATION OF THE WOUND CARE REQUIRED; HOWEVER, THE REPORTER DECLINED TO PROVIDE ANY ADDITIONAL DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223417 HYGH-TEC TUBES, GASTROINTESTINAL KNT ADVANCED MEDICAL BALLOONS GMBH V01-10024 2414001 04260566430116

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Other