BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTIFICIAL BOWEL SPHINCTER

    MDR report key: 232073 · Received July 13, 1999

    Report

    Report Number
    2183959-1999-00029
    Event Type
    Injury
    Date Received
    July 13, 1999
    Date of Event
    June 14, 1999
    Report Date
    July 13, 1999
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    EZY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE ENTIRE DEVICE WAS REMOVED FROM THE PATIENT DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTIFICIAL BOWEL SPHINCTER Implant ARTIFICIAL BOWEL SPHINCTER EZY AMERICAN MEDICAL SYSTEMS, INC. * CO878 005,CW708 001,CX070 017

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R