BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K-UMI MANIPULATOR, SIZE 5 MM, LENGTH 33CM

    MDR report key: 20256385 · Received September 19, 2024

    Report

    Report Number
    20256385
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Date of Event
    July 6, 2024
    Report Date
    September 9, 2024
    Manufacturer
    CATHETER RESEARCH, INC. (THOMAS MEDICAL)
    Product Code
    LKF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FOUND PART OF HUMI MANIPULATOR (BALLOON PORTION) IN PATIENT'S VAGINA DURING AN OFFICE VISIT. PATIENT UNDERWENT LAPAROSCOPY WITH LEFT PARTIAL SALPINGECTOMY OVER ONE MONTH PRIOR. THE HUMI MANIPULATOR WAS INSERTED INTO THE UTERINE CAVITY FOR MANIPULATION OF THE UTERUS. SURGEON DID DISCLOSE TO THE PATIENT THE OBJECT WAS RETAINED FROM THE SURGERY. PER DOCTOR, STARTED PATIENT ON ANTIBIOTICS, AND WILL RETURN RETAINED ITEM BACK TO HOSPITAL FOR INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1691771 K-UMI MANIPULATOR, SIZE 5 MM, LENGTH 33CM CANNULA, MANIPULATOR/INJECTOR, UTERINE LKF CATHETER RESEARCH, INC. (THOMAS MEDICAL) TMI6003

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Other