BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITIND, WITH SNARE, STERILE

    MDR report key: 23437818 · Received October 31, 2025

    Report

    Report Number
    2429304-2025-00285
    Event Type
    Injury
    Date Received
    October 31, 2025
    Date of Event
    September 29, 2025
    Report Date
    October 31, 2025
    Manufacturer
    MEDI-TATE LTD.
    Product Code
    QKA
    UDI-DI
    07290015518062
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AT THE POST-IMPLANT VISIT, THE PATIENT STATED PAIN DISRUPTED HIS DAILY ACTIVITIES, AFFECTING HIS ATTENDANCE AT WORK DUE TO DISCOMFORT. HE HAD TO LEAVE WORK EARLY DUE TO INTENSE PAIN AND PRESSURE AND A CONSTANT NEED TO URINATE. THE PATIENT RATED THE PAIN TEN OUT OF TEN. THE PAIN RESOLVED AFTER THE DEVICE REMOVAL VISIT. THERE WERE NO FURTHER REPORTS OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2299746 ITIND, WITH SNARE, STERILE WA2ITA00 QKA MEDI-TATE LTD. WA2ITA00 U1S04122023-1 07290015518062

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Disability