BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIFLO

    MDR report key: 1598555 · Received February 3, 2010

    Report

    Report Number
    1598555
    Event Type
    Injury
    Date Received
    February 3, 2010
    Date of Event
    January 26, 2010
    Report Date
    February 3, 2010
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    MIP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    ACTIFLO RECTAL TUBE WAS PLACED TO DECOMPRESS GUT. PATIENT EXPERIENCED A RECTAL PERFORATION LIKELY CAUSED BY THE RECTAL TUBE PER MD. THE PATIENT HAS SINCE TRANSFERRED OUT AND HAD A MEDICAL CONSULT. PRIOR TO TRANSFERRING, THE PATIENT WAS MEDICALLY MANAGED FOR THE PERFORATION. THE PATIENT HAD A HISTORY OF SBO (SMALL BOWEL OBSTRUCTION) AND OTHER GI FACTORS THAT MAY HAVE PLAYED A PART IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIFLO CATHETER, IMPLANTED, FECAL MIP HOLLISTER INCORPORATED * *

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other| R