BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 800 URINARY CONTROL SYSTEM

    MDR report key: 23362390 · Received October 22, 2025

    Report

    Report Number
    2124215-2025-75773
    Event Type
    Injury
    Date Received
    October 22, 2025
    Date of Event
    February 24, 2025
    Report Date
    February 2, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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.

    Additional Manufacturer Narrative · 0

    DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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. A 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. BASED ON THE INFORMATION AVAILABLE THE CAUSE THAT CONTRIBUTED TO THE REPORTED EVENT CANNOT BE ESTABLISHED; THEREFORE, THE CONCLUSION CODE OF UNABLE TO EXCLUDE DEVICE PROBLEM HAS BEEN CHOSEN. CORRECTION TO FIELD H6: DEVICE CODES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED DIFFICULTY OPERATING THE PUMP AND WAS UNSURE WHETHER HE WAS EMPTYING HIS BLADDER COMPLETELY. THE PATIENT REPORTED BEING CATHETERIZED WHILE THE AUS WAS NOT DEACTIVATED AND WAS TAKING MEDICATION THAT COULD CONTRIBUTE TO URINARY RETENTION. THE PATIENT WAS PROVIDED WITH EDUCATIONAL RESOURCES AND GUIDANCE ON PROPER DEVICE USE. AFTER FOLLOWING THE INSTRUCTIONS, THE PATIENT WAS ABLE TO OPERATE THE DEVICE AND VOID SUCCESSFULLY. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED DIFFICULTY OPERATING THE PUMP AND WAS UNSURE WHETHER HE WAS EMPTYING HIS BLADDER COMPLETELY. THE PATIENT REPORTED BEING CATHETERIZED WHILE THE AUS WAS NOT DEACTIVATED AND WAS TAKING MEDICATION THAT COULD CONTRIBUTE TO URINARY RETENTION. THE PATIENT WAS PROVIDED WITH EDUCATIONAL RESOURCES AND GUIDANCE ON PROPER DEVICE USE. AFTER FOLLOWING THE INSTRUCTIONS, THE PATIENT WAS ABLE TO OPERATE THE DEVICE AND VOID SUCCESSFULLY. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232540 AMS 800 URINARY CONTROL SYSTEM DEVICE INCONTINENCE MECHANICAL/HYDRAULIC EZY BOSTON SCIENTIFIC CORPORATION UNK-P-AUS

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Other