BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 800 URINARY CONTROL SYSTEM

    MDR report key: 17473411 · Received August 7, 2023

    Report

    Report Number
    2124215-2023-41721
    Event Type
    Injury
    Date Received
    August 7, 2023
    Date of Event
    July 19, 2023
    Report Date
    August 7, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZY
    UDI-DI
    00878953000626
    PMA / PMN Number
    P000053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS BROUGHT TO THE OPERATING ROOM DUE TO MALFUNCTIONING AN ARTIFICIAL URINARY SPHINCTER (AUS) DEVICE. UPON INSPECTION OF THE PRESSURE REGULATING BALLOON, IT WAS OBSERVED THAT THERE WAS A BREAK IN THE LINE THAT WAS CAUSING FLUID LEAK. THE AUS WAS DEVICE WAS REPLACED WITH NEW DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1338184 AMS 800 URINARY CONTROL SYSTEM DEVICE INCONTINENCE MECHANICAL/HYDRAULIC EZY BOSTON SCIENTIFIC CORPORATION 72400024 1000115722 00878953000626

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Hospitalization| R