BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIFLO

    MDR report key: 3691972 · Received March 10, 2014

    Report

    Report Number
    3691972
    Event Type
    Injury
    Date Received
    March 10, 2014
    Date of Event
    February 3, 2012
    Report Date
    February 21, 2012
    Manufacturer
    ROBLING MEDICAL, INC.
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    HOLLISTER ACTIFLO RECTAL TUBE WAS INSERTED FOR DIARRHEA DUE TO C. DIFFICILE. THERE WAS A SMALL AMOUNT OF BLOOD AROUND THE TUBE A FEW DAYS LATER. THE TUBE WAS REMOVED WITH A LARGE AMOUNT OF RECTAL BLEEDING. THE PATIENT BECAME HYPOTENSIVE WITH A LARGE AMOUNT OF RECTAL BLEEDING, DROP IN HEMOGLOBIN AND HEMATOCRIT, TRANSFUSION AND EVENTUALLY EMBOLIZATION TO OF SUPERIOR RECTAL ARTERY. PATIENT WAS STABILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143600 ACTIFLO TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ROBLING MEDICAL, INC. 32005 *

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other| R