BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 800 ARTIFICIAL URINARY SPHINCTER

    MDR report key: 23325220 · Received October 17, 2025

    Report

    Report Number
    2124215-2025-74089
    Event Type
    Injury
    Date Received
    October 17, 2025
    Date of Event
    April 24, 2025
    Report Date
    December 2, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZY
    UDI-DI
    00878953003108
    PMA / PMN Number
    P000053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT PRODUCT UDI FOR PUMP IS (B)(4). CONCOMITANT PRODUCT UDI FOR BALLOON IS (B)(4).

    Additional Manufacturer Narrative · 0

    CONCOMITANT PRODUCT UDI FOR PUMP IS (B)(4). CONCOMITANT PRODUCT UDI FOR BALLOON IS (B)(4). 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. THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE THE CAUSE THAT CONTRIBUTED TO THE REPORTED EVENT CANNOT BE ESTABLISHED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXHIBITED A PROBLEM, AS THE CUFF COULD NOT BE EMPTIED. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE AUS. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXHIBITED A PROBLEM, AS THE CUFF COULD NOT BE EMPTIED. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE AUS. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299595 AMS 800 ARTIFICIAL URINARY SPHINCTER DEVICE INCONTINENCE MECHANICAL/HYDRAULIC EZY BOSTON SCIENTIFIC CORPORATION 72404132 1100562262 00878953003108

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Hospitalization| R BALLOON: UPN: 72400023 / LOT: 1100066746.| PUMP: UPN: 72404130 / LOT: 1100449015.