BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZASSI BOWEL MANAGEMENT SYSTEM

    MDR report key: 920853 · Received September 27, 2007

    Report

    Report Number
    1480288-2007-00006
    Event Type
    Other
    Date Received
    September 27, 2007
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    KNT
    Report Source
    Manufacturer report
    Reporter Location
    CA, US

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION INDICATED A TEAR IN TRANSSPHINCTERIC ZONE TUBE MATERIAL. CAUSE OF TEAR UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRODUCT CAME APART IN THE PATIENT. ALL PARTS WERE RETRIEVED FROM THE PATIENT AND SAVED. NO APPARENT INJURY WAS SUSTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZASSI BOWEL MANAGEMENT SYSTEM RECTAL CATHETER KNT HOLLISTER INCORPORATED

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention