BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZASSI BOWEL MANAGEMENT SYSTEM

    MDR report key: 858623 · Received May 31, 2007

    Report

    Report Number
    1480288-2007-00001
    Event Type
    Death
    Date Received
    May 31, 2007
    Manufacturer
    HOLLISTER, INC.
    Product Code
    KNT
    PMA / PMN Number
    K023344
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO US: A RECTAL CATHETER WAS INSERTED INTO AN ADULT FEMALE PATIENT WHO SUFFERED FROM SEVERE LIVER CIRRHOSIS. THE PATIENT DEVELOPED RECTAL BLEEDING FOUR DAYS AFTER THE DEVICE WAS INSERTED. THE DEVICE WAS REMOVED AND THE PATIENT CONTINUED TO BLEED. ENDOSCOPY WAS PERFORMED AND IT WAS DETERMINED THE PATIENT DEVELOPED AN ULCERATION. THE BLEEDING DID NOT STOP AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZASSI BOWEL MANAGEMENT SYSTEM RECTAL CATHETER KNT HOLLISTER, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death