BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACTIFLO INDWELLING BOWEL CATHETER SYSTEM

    MDR report key: 1625067 · Received February 18, 2010

    Report

    Report Number
    1480288-2010-00002
    Event Type
    Other
    Date Received
    February 18, 2010
    Report Date
    February 17, 2010
    Manufacturer
    HOLLISTER, INC.
    Product Code
    KNT
    PMA / PMN Number
    K083153
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION WAS PROVIDED. HOSPITAL STATED THEY ARE WELL VERSED IN THE USE OF THE DEVICE AND CONSIDER THIS TO BE AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PT WAS ADMITTED TO THE HOSPITAL FOR EXCORIATION ON HER BODY. AN ACTIFLO INDWELLING BOWEL CATHETER WAS INSERTED FOR FECAL DISCHARGE MANAGEMENT DURING THE HEALING PROCESS. AFTER 19 DAYS, RECTAL BLEEDING WAS NOTED AND THE DEVICE WAS REMOVED. THE PT WAS SCOPED AND AN ULCERATION WAS NOTED ON THE RECTAL WALL. THE DOCTOR ORDERED THE DEVICE TO BE RE-INSERTED WITH LESS WATER IN THE RETENTION CUFF OF THE DEVICE IN ORDER TO MINIMIZE CUFF PRESSURE. IT WAS REPORTED THAT THE BLEEDING STOPPED WITH NO INTERVENTION AND THE USE OF THE DEVICE WAS CONTINUED WITHOUT FURTHER INCIDENT. PT WAS DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIFLO INDWELLING BOWEL CATHETER SYSTEM ACTIFLO RECTAL CATHETER KNT HOLLISTER, INC. 32004

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other