BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PEG TUBE

    MDR report key: 25185375 · Received May 15, 2026

    Report

    Report Number
    2026095-2026-00037
    Event Type
    Injury
    Date Received
    May 15, 2026
    Report Date
    May 15, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6-HEALTH EFFECT - CLINICAL CODE/4581 - APPROPRIATE TERM / CODE NOT AVAILABLE: BURIED BUMPER SYNDROME. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED; THEREFORE, THE UDI-PI IS UNAVAILABLE. THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. ALL INFORMATION REASONABLY KNOWN AS OF 15-MAY-2026 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AVANOS MEDICAL, INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AVANOS MEDICAL, INC. AVANOS MEDICAL, INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AVANOS MEDICAL, INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE DEVELOPED BURIED BUMPER SYNDROME, LEADING TO DISLODGEMENT AND REQUIRING HOSPITALIZATION, INTRAVENOUS (IV) FLUIDS, AND REPLACEMENT PROCEDURES WHILE THE STOMA HEALED. ADDITIONAL INFORMATION NOTED THE PATIENT UNDERWENT A PEG CHANGE IN JANUARY WHEN THE TUBE BECAME DISLODGED. IT SEEMS LIKELY THAT THE PATIENT WAS INADVERTENTLY MANIPULATING THE TUBE AND PULLING ON IT WHICH COULD CONTRIBUTE TO THE DISLODGEMENT AS SOMETIMES TUBES CAN BE TRAPPED. THE PATIENT "SEEMED A BIT BETTER ON THE HIGHER DOSE WHICH REDUCED THE RIGHT-HAND TREMOR TO ENABLE HER TO EAT WITH MILD DYSKINESIA." THE PATIENT IS CONFUSED WITHOUT SIGNIFICANT HALLUCINATIONS. HER BLOOD PRESSURE WAS SATISFACTORY. HER VITAMIN B6 LEVELS WERE SATISFACTORY. WITH RECURRENT PEG TUBE DISPLACEMENTS REQUIRING ADMISSION, AN AESTHETICS AND PROCEDURES AND IN VIEW OF ADVANCING DISEASE. IT WAS SUGGESTED THE PROVIDER TRY REVERTING TO ORAL MEDICATION NEXT TIME THERE IS A PEG TUBE PROBLEM RATHER THAN IMMEDIATELY CHANGING THE TUBE. THE PATIENT HAS BEEN ON THE DUODOPA NOW FOR MORE THAN FIVE YEARS. IF SHE NEEDS TO CHANGE TO ORAL MEDICATION, IT WAS ALSO SUGGESTED INITIALLY SWITCHING TO LEVODOPA/BENSERAZIDE 100/25MG A HALF TABLET FOURTH HOURLY FOR FOUR DOSES IN THE DAY AND REMAINING ON THE SLOW RELEASE AT NIGHT WITH ADJUSTMENTS TO BE MADE, DEPENDING ON THE PATIENT'S PROGRESS AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562138 UNKNOWN PEG TUBE DH EF PEG INITIAL PLACEMENT PRODUCTS KNT AVANOS MEDICAL INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other