BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITIND, WITH SNARE, STERILE

    MDR report key: 25255745 · Received May 22, 2026

    Report

    Report Number
    2429304-2026-00058
    Event Type
    Injury
    Date Received
    May 22, 2026
    Date of Event
    April 27, 2026
    Report Date
    May 22, 2026
    Manufacturer
    MEDI-TATE LTD.
    Product Code
    QKA
    UDI-DI
    07290015518062
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO URINATE SINCE THE ITIND PROCEDURE. THE PATIENT PRESENTED TO THE EMERGENCY ROOM AROUND MIDNIGHT WITH ACUTE URINARY RETENTION. IT WAS NOTED THAT THE BLADDER SCAN SHOWED OVER 800 ML OF FLUIDS AND A CATHETER WAS PLACED TO DRAIN THE BLADDER. THE PATIENT WAS THEN DISCHARGE WITH A CATHETER AND URINE BAG IN PLACED. THE PLAN IS TO KEEP THE CATHETER UNTIL THE RETRIEVAL OF THE ITIND DEVICE. THERE WERE NO FURTHER REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68281 ITIND, WITH SNARE, STERILE WA2ITA00 QKA MEDI-TATE LTD. WA2ITA00 UISI3022024-2 07290015518062

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention