BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITIND, WITH SNARE, STERILE

    MDR report key: 21691538 · Received March 25, 2025

    Report

    Report Number
    2429304-2025-00106
    Event Type
    Injury
    Date Received
    March 25, 2025
    Date of Event
    February 6, 2025
    Report Date
    March 25, 2025
    Manufacturer
    MEDI-TATE LTD.
    Product Code
    QKA
    UDI-DI
    07290015518062
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED AFTER REMOVAL OF AN ITIND, ON AN UNSPECIFIED DATE, THE PATIENT ACQUIRED A URINARY TRACT INFECTION AND WAS SUBSEQUENTLY ADMITTED TO THE HOSPITAL FOR SEPSIS. IT WAS NOTED THAT THE REMOVAL OF THE ITIND DID NOT GO IDEALLY AS THE DEVICE DID NOT COME FULLY INTO THE REMOVAL CATHETER. THERE WERE NO FURTHER REPORTS OF PATIENT HARM. DESPITE MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION, NONE WAS OBTAINED. THIS REPORT IS LINKED TO THE FOLLOWING PATIENT IDENTIFIER: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059109 ITIND, WITH SNARE, STERILE WA2ITA0R QKA MEDI-TATE LTD. WA2ITA00 NI 07290015518062

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization WA2ITA00