BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLEANSING ENEMA SET

    MDR report key: 20913491 · Received December 10, 2024

    Report

    Report Number
    MW5163497
    Event Type
    Other
    Date Received
    December 10, 2024
    Date of Event
    November 12, 2024
    Report Date
    December 5, 2024
    Manufacturer
    MEDLINE INDUSTRIES, LP - MEXICALI (MXC)
    Product Code
    FCE
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RN WAS ADMINISTERING A LACTULOSE ENEMA. AFTER THE ENEMA WAS ADMINISTERED, THE RN REALIZED THAT THE CAP OF THE ENEMA TUBING WAS NOT TAKEN OFF AND WAS INSERTED INTO THE RECTUM. ONCE THE RN NOTICED THE MISTAKE, HE NOTIFIED THE PROVIDER AND THE PROVIDERS CAME TO THE BEDSIDE. THIS PATIENT WENT FOR A SIGMOIDOSCOPY FOR REMOVAL. THE PATIENT RECOVERED WELL FROM THE PROCEDURE. SUBMITTING FOR POTENTIAL CHANGE IN DESIGN FOR CAP SO IT CANNOT BE INSERTED INTO RECTUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2415038 CLEANSING ENEMA SET ENEMA KIT FCE MEDLINE INDUSTRIES, LP - MEXICALI (MXC)

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Other