BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITIND

    MDR report key: 20248332 · Received September 17, 2024

    Report

    Report Number
    MW5159710
    Event Type
    Injury
    Date Received
    September 17, 2024
    Date of Event
    August 8, 2024
    Report Date
    September 16, 2024
    Manufacturer
    MEDI-TATE
    Product Code
    QKA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ITIND IMPLANT REMOVAL STRING BROKE DURING REMOVAL PROCESS AT PATIENT'S BEDSIDE. PATIENT HAD TO GO TO OPERATING ROOM TO SURGICALLY REMOVE ITIND DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2296324 ITIND TEMPORARILY-PLACED URETHRAL OPENING SYSTEM FOR SYMPTOMS OF BENIGN PROSTATIC HYPE QKA MEDI-TATE 28112022-1

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Male Hospitalization