BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZASSI BOWEL MANAGEMENT SYSTEM

    MDR report key: 515481 · Received February 20, 2004

    Report

    Report Number
    3003416713-2004-00001
    Event Type
    Injury
    Date Received
    February 20, 2004
    Date of Event
    January 20, 2004
    Report Date
    February 19, 2004
    Manufacturer
    ZASSI MEDICAL EVOLUTIONS
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT IS ALLEGED THAT THE RETENTION CUFF OF THE CATHETER SEPARATED FROM THE CATHETER ASSEMBLY DURING REMOVAL OF THE CATHETER NECESSITATING THE REMOVAL OF THE CUFF FROM THE PT BY USE OF FORCEPS BY A HEALTHCARE PROFESSIONAL. NO PERMANENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZASSI BOWEL MANAGEMENT SYSTEM GASTROINTESTINAL TUBE KNT ZASSI MEDICAL EVOLUTIONS 300-02-0006 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention