BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITIND, WITH SNARE, STERILE

    MDR report key: 20392606 · Received October 7, 2024

    Report

    Report Number
    2429304-2024-0000434
    Event Type
    Injury
    Date Received
    October 7, 2024
    Date of Event
    September 16, 2024
    Report Date
    October 7, 2024
    Manufacturer
    MEDI-TATE, LTD
    Product Code
    KOE
    UDI-DI
    07290015518062
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SUBJECT DEVICE WAS DEPLOYED BLINDLY IN THE PATIENT'S BLADDER THROUGH A RIGID CYSTOSCOPE SHEATH DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. THE DEVICE SLIGHTLY PUNCTURED THE BLADDER CAUSING A SMALL PERFORATION. THERE WAS NO INTRAPERITONEAL INJURY, SO THE DOCTOR DECIDED TO PLACE THE DEVICE WHILE LEAVING A CATHETER TO ASSIST IN VOIDING AND HEALING. THE PATIENT SINCE HAD THE DEVICE REMOVED AND WAS STATED TO BE DOING FINE. THE DOCTOR PLANS ON SCOPING THE PATIENT IN 3 MONTHS FOR FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247221 ITIND, WITH SNARE, STERILE WA2ITA00 KOE MEDI-TATE, LTD WA2ITA00 27102022-1 07290015518062

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention