BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE

    MDR report key: 10293625 · Received July 19, 2020

    Report

    Report Number
    2183959-2020-03026
    Event Type
    Injury
    Date Received
    July 19, 2020
    Date of Event
    January 1, 2019
    Report Date
    July 19, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZY
    UDI-DI
    00878953005652
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT REVISION PROCEDURE OF IS ARTIFICIAL URINARY SPHINCTER (AUS) DUE TO INCONTINENCE INCREASED OVER THE PAST YEAR. ALL COMPONENTS WERE EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757902 AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE DEVICE INCONTINENCE MECHANICAL/HYDRAULIC EZY BOSTON SCIENTIFIC CORPORATION 720157-01 1000271944 00878953005652

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R