BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITIND, WITH SNARE, STERILE

    MDR report key: 23182019 · Received September 30, 2025

    Report

    Report Number
    2429304-2025-00254
    Event Type
    Injury
    Date Received
    September 30, 2025
    Date of Event
    July 1, 2025
    Report Date
    September 30, 2025
    Manufacturer
    MEDI-TATE LTD.
    Product Code
    QKA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED DURING THE ONE-MONTH FOLLOW-UP VISIT POST ITIND PROCEDURE, THE PATIENT HAD FOUL SMELLING URINE. A URINE CULTURE WAS DONE AND CAME BACK POSITIVE. THE PATIENT WAS TREATED WITH ANTIBIOTICS. THE URINARY TRACT INFECTION WAS ONGOING. THERE WERE NO FURTHER REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2216015 ITIND, WITH SNARE, STERILE WA2ITA00 QKA MEDI-TATE LTD. WA2ITA00 U1S04122023-1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention