BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITIND, WITH SNARE, STERILE

    MDR report key: 19343480 · Received May 17, 2024

    Report

    Report Number
    2429304-2024-00260
    Event Type
    Injury
    Date Received
    May 17, 2024
    Date of Event
    January 18, 2024
    Report Date
    May 17, 2024
    Manufacturer
    MEDI-TATE LTD.
    Product Code
    KOE
    UDI-DI
    07290015518062
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT CALLED IN ON (B)(6) 2024 WITH COMPLAINT OF HEMATURIA AND CAME FOR A VISIT ON (B)(6) 2024. IT WAS NOTED PATIENT HAD HEMATOSPERMIA. SEMEN CULTURE (SAMPLE COLLECTED ON (B)(6) 2024) RESULTED IN DIAGNOSIS OF PROSTATITIS ((B)(6) 2024). AND PATIENT WAS ADMINISTERED LEVAQUIN FOR POSSIBILITY OF INFECTION. DETAILS OF THE PATIENT'S CURRENT CONDITION, PROCEDURAL DETAILS AND OUTCOME OF THE PROCEDURE WERE REQUESTED BUT NOT AVAILABLE AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919703 ITIND, WITH SNARE, STERILE ITIND SYSTEM KOE MEDI-TATE LTD. WA2ITA00 U1S02052022-1 07290015518062

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention