BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACTIFLO INDWELLING BOWEL CATHETER SYSTEM

    MDR report key: 1769458 · Received July 22, 2010

    Report

    Report Number
    1480288-2010-00006
    Event Type
    Other
    Date Received
    July 22, 2010
    Report Date
    July 22, 2010
    Manufacturer
    HOLLISTER, INC.
    Product Code
    MIP
    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 AN INCIDENT OCCURRED WITH A LIVER TRANSPLANT PT WHERE THE PT DEVELOPED RECTAL BLEEDING WHILE USING THE ACTIFLO INDWELLING BOWEL CATHETER SYSTEM. NO FURTHER INFO WAS ABLE TO BE OBTAINED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention