BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 800 URINARY CONTROL SYSTEM

    MDR report key: 23898108 · Received December 26, 2025

    Report

    Report Number
    2124215-2025-93197
    Event Type
    Injury
    Date Received
    December 26, 2025
    Date of Event
    December 1, 2025
    Report Date
    February 11, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THERE WAS NO REPORT OF A DEVICE PERFORMANCE ALLEGATION. A DEVICE HISTORY RECORD (DHR) AND SHIP HISTORY REVIEW CANNOT BE PERFORMED AS THE LOT NUMBER WAS NOT AVAILABLE. A REVIEW OF THE DEVICE INSTRUCTIONS FOR USE (IFU) WAS COMPLETED AND DID NOT REVEAL ANY EVIDENCE OF DEVICE MISUSE, OFF LABEL USE, OR FAILURE TO FOLLOW INSTRUCTIONS. THE REPORTED PATIENT SYMPTOM(S) ARE KNOWN RISK ASSOCIATED WITH THIS DEVICE TYPE AND INDICATED AS SUCH IN THE INSTRUCTIONS FOR USE. CORRECTION TO FIELD H6: IMPACT CODES.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THERE WAS NO REPORT OF A DEVICE PERFORMANCE ALLEGATION. THE REPORTED PATIENT SYMPTOMS ARE KNOWN RISKS ASSOCIATED WITH THIS DEVICE TYPE AND INDICATED AS SUCH IN THE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SURGICAL PROCEDURE WAS INITIATED FOR REMOVAL OF AN ARTIFICIAL URINARY SPHINCTER (AUS) DUE TO INCONTINENCE AND EROSION. DURING THE PROCEDURE, AN ACCESSORY DEVICE WAS OPENED AND CROSSED THE STERILE FIELD; HOWEVER, THE PHYSICIAN CHANGED THE COURSE OF ACTION, AND THE DEVICE WAS NOT USED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SURGICAL PROCEDURE WAS INITIATED FOR REMOVAL OF AN ARTIFICIAL URINARY SPHINCTER (AUS) DUE TO INCONTINENCE AND EROSION. DURING THE PROCEDURE, AN ACCESSORY DEVICE WAS OPENED AND CROSSED THE STERILE FIELD; HOWEVER, THE PHYSICIAN CHANGED THE COURSE OF ACTION, AND THE DEVICE WAS NOT USED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2313020 AMS 800 URINARY CONTROL SYSTEM DEVICE INCONTINENCE MECHANICAL/HYDRAULIC EZY BOSTON SCIENTIFIC CORPORATION UNK-P-AUS

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Other