BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITIND, WITH SNARE, STERILE

    MDR report key: 20922258 · Received December 13, 2024

    Report

    Report Number
    2429304-2024-01037
    Event Type
    Injury
    Date Received
    December 13, 2024
    Date of Event
    November 22, 2024
    Report Date
    December 12, 2024
    Manufacturer
    MEDI-TATE LTD.
    Product Code
    QKA
    UDI-DI
    07290015518062
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE REMOVAL PROCEDURE OF THE SUBJECT DEVICE, THE SUTURE THAT IS USED TO PULL THE DEVICE INTO A CATHETER BROKE. THE PATIENT HAD TO BE MOVED TO THE OPERATING ROOM TO HAVE THE SUBJECT DEVICE SURGICALLY REMOVED USING A CYSTOSCOPE. THE SUBJECT DEVICE WAS SUCCESSFULLY REMOVED. THERE WERE NO REPORTS OF FURTHER PATIENT OR USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1859319 ITIND, WITH SNARE, STERILE WA2ITA00 QKA MEDI-TATE LTD. WA2ITA00 17092022-1 07290015518062

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention