BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACTIFLO INDWELLING BOWEL CATHETER SYSTEM

    MDR report key: 1769459 · Received July 22, 2010

    Report

    Report Number
    1480288-2010-00007
    Event Type
    Other
    Date Received
    July 22, 2010
    Report Date
    July 22, 2010
    Manufacturer
    HOLLISTER, INC.
    Product Code
    KNT
    PMA / PMN Number
    K083153
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFO WAS PROVIDED. AS REPORTED BY THE USER FACILITY, THE PT WAS NOTED TO BE A LUNG TRANSPLANT PT. NO OTHER INFO WAS ABLE TO BE OBTAINED. THE INCIDENT OCCURRED APPROX 6 MONTHS PRIOR TO REPORTING THE INCIDENT TO HOLLISTER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LUNG TRANSPLANT PT HAD AN ACTIFLO INDWELLING BOWEL CATHETER SYSTEM IN SITU BETWEEN 5 AND 14 DAYS PRIOR TO DEVELOPING RECTAL BLEEDING. PER THE NURSE, A BLOOD TRANSFUSION WAS GIVEN AND THE WOUND WAS CAUTERIZED. THE NURSE WAS NOT IN A POSITION TO REVIEW THE MEDICAL CHARTS AND NO FURTHER INFO COULD BE OBTAINED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention