BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACTIFLO INDWELLING BOWEL CATHETER SYSTEM

    MDR report key: 1884157 · Received October 14, 2010

    Report

    Report Number
    1480288-2010-00011
    Event Type
    Other
    Date Received
    October 14, 2010
    Report Date
    October 13, 2010
    Manufacturer
    HOLLISTER, INC.
    Product Code
    MIP
    PMA / PMN Number
    K083153
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON INVESTIGATION, IT WAS DETERMINED THAT PT HAD A COLONOSCOPY IN (B)(4) 2010, AT WHICH TIME RECTAL ULCERATIONS WERE NOTED. THE NURSES INSERTED THE DEVICE WITHOUT FURTHER GI CONSULT. THE CONSEQUENT INVESTIGATION INTO THE SOURCE OF THE BLEED IDENTIFIED THE AREA OF ULCERATION TO BE IN THE SAME PLACE AS THE AREA NOTED DURING THE JULY COLONOSCOPY. IN A CONSEQUENT CONVERSATION IT WAS RELATED THAT THE PT HAD EXPIRED FROM UNRELATED ILLNESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD EXHIBITED RECTAL BLEEDING WHILE USING AN ACTIFLO INDWELLING BOWEL CATHETER SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIFLO INDWELLING BOWEL CATHETER SYSTEM ACTIFLO RECTAL CATHETER MIP HOLLISTER, INC. 32004 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other