BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECTAL INSERT

    MDR report key: 24581224 · Received March 11, 2026

    Report

    Report Number
    MW5185113
    Event Type
    Injury
    Date Received
    March 11, 2026
    Report Date
    April 16, 2026
    Manufacturer
    WELLSPECT HEALTHCARE
    Product Code
    KNT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PATIENT EXPERIENCED TRANSANAL IRRIGATION DIFFICULTIES AFTER RECEIVING THE NAVINA DEVICE FOR BOWEL MANAGEMENT. THE DEVICE WAS NOT WORKING AS INTENDED, AND PATIENT REPORTED HAVING DIARRHEA FOR HOURS. PATIENT HAS STOPPED USING THE NAVINA DEVICE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 04/16/2026 FOR REPORT MW5185113 TO UPDATE THE MANUFACTURER AND PROCODE. PROCODE: KNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637679 RECTAL INSERT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT WELLSPECT HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other