BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITIND, WITH SNARE, STERILE

    MDR report key: 20909702 · Received December 11, 2024

    Report

    Report Number
    2429304-2024-01033
    Event Type
    Injury
    Date Received
    December 11, 2024
    Date of Event
    November 14, 2024
    Report Date
    December 11, 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 THE PATIENT EXPERIENCED ACUTE URINARY RETENTION FOLLOWING THE APPLICATION OF THE SUBJECT DEVICE. IT WAS NOTED THAT DUE TO THE PATIENT'S ANATOMICAL PRESENTATION, THERE WAS DIFFICULTY IN THE APPLICATION OF THE SUBJECT DEVICE, CONTRIBUTING TO THE RETENTION. THE PATIENT PRESENTED TO THE EMERGENCY ROOM AND WAS HOSPITALIZED FOR MANAGEMENT OF URINARY RETENTION. THE TREATMENT INCLUDED FOLEY CATHETER PLACEMENT, INTRAVENOUS ANTIBIOTICS FOR SUSPECTED INFECTION, INTRAVENOUS HYDRATION, AND MONITORING OF RENAL FUNCTION. THE URINARY RETENTION LED TO ACUTE KIDNEY INJURY, WHICH WAS RESOLVED WITH MANAGEMENT DURING THE STAY. DURING THE HOSPITALIZATION, THE SUBJECT DEVICE WAS REMOVED. ADDITIONALLY, AS REPORTED, THE HOSPITALIZATION WAS PROLONGED DUE TO THE PATIENT'S PRE-EXISTING CONDITIONS, INCLUDING ADRENAL INSUFFICIENCY, POORLY CONTROLLED DIABETES, AND CHRONIC IMMUNOSUPPRESSION THERE WERE NO REPORTS OF FURTHER PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2026954 ITIND, WITH SNARE, STERILE WA2ITA00 QKA MEDI-TATE LTD. WA2ITA00 15032023-1 07290015518062

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R