BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON SCIENTIFIC CORPORATION

    MDR report key: 23065242 · Received September 16, 2025

    Report

    Report Number
    2124215-2025-64303
    Event Type
    Injury
    Date Received
    September 16, 2025
    Date of Event
    July 22, 2025
    Report Date
    September 16, 2025
    Manufacturer
    MARLBOROUGH
    Product Code
    EZY
    UDI-DI
    00878953003108
    PMA / PMN Number
    P000053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO DEVICE AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED PATIENT SYMPTOM OF URETHRAL STRICTURE IS A KNOWN RISK ASSOCIATED WITH IMPLANT OF THESE DEVICE AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). BASED ON THE INFORMATION AVAILABLE, A CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE WAS ASSIGNED TO THIS INVESTIGATION. D4. CONCOMITANT PRODUCT UDI FOR PUMP IS (B)(4) AND FOR BALLOON IS (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED URETHRAL STRICTURE. AS A RESULT, THE CUFF WAS EXPLANTED. THREE WEEKS LATER, A NEW CUFF WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2561455 BOSTON SCIENTIFIC CORPORATION 300 BOSTON SCIENTIFIC WAY EZY MARLBOROUGH FAHIMI 1100184506 00878953003108

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Unknown Hospitalization| R