BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITIND, WITH SNARE, STERILE

    MDR report key: 15971420 · Received December 13, 2022

    Report

    Report Number
    2429304-2022-00166
    Event Type
    Injury
    Date Received
    December 13, 2022
    Date of Event
    November 14, 2022
    Report Date
    December 13, 2022
    Manufacturer
    MEDI-TATE LTD.
    Product Code
    MER
    UDI-DI
    07290015518062
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS AFTER AN ITIND REMOVAL PROCEDURE, THE PATIENT RETURNED A FEW HOURS AFTER REMOVAL, WITH COMPLAINTS OF URINARY RETENTION. A 16FR FOLEY CATHETER WAS PLACED AND 480 ML OF RED COLORED URINE WAS DRAINED. PATIENT WILL RETURN AT A LATER DATE TO HAVE CATHETER REMOVED. NO FURTHER CONSEQUENCES TO THE PATIENT WERE REPORTED. REPRESENTATIVE PROCODE MER CHOSEN IN FIELD. ACTUAL PROCODE QKA FOR ITIND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385899 ITIND, WITH SNARE, STERILE BARE-METAL URETHRAL STENT, SHORT-TERM MER MEDI-TATE LTD. WA2ITA00 U1S02052022-1 07290015518062

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention