BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIFLO INDWELLING BOWEL CATHETER SYSTEM

    MDR report key: 1625929 · Received March 4, 2010

    Report

    Report Number
    1480288-2010-00004
    Event Type
    Injury
    Date Received
    March 4, 2010
    Date of Event
    January 26, 2010
    Report Date
    March 4, 2010
    Manufacturer
    HOLLISTER, INC.
    Product Code
    KNT
    PMA / PMN Number
    K083153
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADD'L INFO WAS PROVIDED. AS REPORTED BY THE USER FACILITY, THE PT HAD A HISTORY OF SMALL BOWEL OBSTRUCTIONS AND OTHER GI FACTORS THAT MAY HAVE PLAYED A PART IN THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WITH A HISTORY OF SMALL BOWEL OBSTRUCTION AND OTHER GI PROBLEMS WAS NOTED TO HAVE A BOWEL PERFORATION WHILE THE ACTIFLO INDWELLING CATHETER WAS IN PLACE. PER THE USER FACILITY, THE PT WAS MEDICALLY MANAGED FOR THE PERFORATION AND NO SURGICAL INTERVENTION WAS NEEDED. THE PT HAS SINCE BEEN TRANSFERRED.

    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 40 YR Other