BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIFLO BOWEL CATHETER SYSTEM

    MDR report key: 3797362 · Received May 7, 2014

    Report

    Report Number
    1480288-2014-00002
    Event Type
    Injury
    Date Received
    May 7, 2014
    Date of Event
    February 3, 2012
    Report Date
    May 7, 2014
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    KNT
    PMA / PMN Number
    K083153
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED IN (B)(6) OF 2012. WHEN CONTACTED, THE HOSPITAL PERSONNEL DID NOT REMEMBER THIS REPORT. HOLLISTER PROVIDED THE HOSPITAL WITH A COPY OF THE MED WATCH WHICH HAD BEEN SENT TO THE FDA IN (B)(4) OF 2014. NO FURTHER INFORMATION COULD BE PROVIDED BY THE HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ACTIFLO BOWEL CATHETER WAS INSERTED IN THE PATIENT (ADMITTED FOR SUBDURAL HEMATOMA) 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 BLEEDING, DROP IN HEMOGLOBIN, AND HEMATOCRIT, TRANSFUSION AND EVENTUALLY EMBOLIZATION OF SUPERIOR RECTAL ARTERY. PATIENT WAS STABILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273412 ACTIFLO BOWEL CATHETER SYSTEM ACTIFLO BOWEL CATHETER KNT HOLLISTER INCORPORATED 32005

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention