BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIFLO INDWELLING BOWEL CATHETER SYSTEM

    MDR report key: 1884098 · Received October 21, 2010

    Report

    Report Number
    1480288-2010-00012
    Event Type
    Injury
    Date Received
    October 21, 2010
    Date of Event
    June 2, 2010
    Report Date
    October 21, 2010
    Manufacturer
    HOLLISTER, INC.
    Product Code
    KNT
    PMA / PMN Number
    K083153
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION WAS PROVIDED. IT WAS REPORTED BY THE USER FACILITY THAT THE PATIENT HAD AN ACTIFLO INDWELLING BOWEL CATHETER INSERTED FROM (B)(6), 2010. HOWEVER, IT WAS NOTED THAT THE PATIENT EXPERIENCED SEVERAL EXPULSIONS OF THE CATHETER FROM (B)(6), 2010, SO A SECOND CATHETER WAS INSERTED ON (B)(6) AND USED THROUGH THE TIME OF THE INCIDENT ON (B)(6), 2010. THE INSTRUCTIONS FOR USE INDICATE THAT IF EXPULSION FREQUENCY IS EXCESSIVE, CONSIDER DISCONTINUING USE OF PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PATIENT WITH A LIVER CONDITION EXPERIENCED A LOWER GI BLEED. A COLONOSCOPY WAS PERFORMED AND A RECTAL ULCER WAS OBSERVED AT THE APPROXIMATE LEVEL OF THE RETENTION CUFF. CAUTERIZATION WAS PERFORMED AND A BLOOD TRANSFUSION WAS ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIFLO INDWELLING BOWEL CATHETER SYSTEM ACTIFLO RECTAL CATHETER KNT HOLLISTER, INC. 32005 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other