BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 800 ARTIFICIAL URINARY SPHINCTER

    MDR report key: 23712973 · Received December 4, 2025

    Report

    Report Number
    2124215-2025-87123
    Event Type
    Injury
    Date Received
    December 4, 2025
    Date of Event
    November 6, 2025
    Report Date
    December 4, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZY
    UDI-DI
    00878953003078
    PMA / PMN Number
    P000053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED DEVICE PERFORMANCE ALLEGATION CANNOT BE CONFIRMED. BASED ON THE INFORMATION AVAILABLE THE CAUSE THAT CONTRIBUTED TO THE REPORTED EVENT CANNOT BE ESTABLISHED. D4. CONCOMITANT PRODUCT UDI FOR BALLOON IS (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP OF THIS ARTIFICIAL URINARY SPHINCTER (AUS) MIGRATED FROM ITS ORIGINAL POSITION. AS A RESULT, THE PUMP WAS REVISED. NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1892027 AMS 800 ARTIFICIAL URINARY SPHINCTER DEVICE INCONTINENCE MECHANICAL/HYDRAULIC EZY BOSTON SCIENTIFIC CORPORATION 72404127 1100709763 00878953003078

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention| H