BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 800 URINARY CONTROL SYSTEM

    MDR report key: 19867368 · Received July 30, 2024

    Report

    Report Number
    2124215-2024-45591
    Event Type
    Injury
    Date Received
    July 30, 2024
    Date of Event
    April 25, 2024
    Report Date
    July 30, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    KENTARO TAKEZAWA, HIROAKI KITAKAZE, GO TSU-JIMURA, TAKAHIRO IMANAKA, SOHEI JURIBAYASHI, NORICHIKA UEDA, FUKUHARA SHINICHIRO, NORIO NONO-MURA. OUTCOMES OF ARTIFICIAL URINARY SPHINCTER IMPLANTATION: A SINGLE-CENTER RETROSPECTIVE STUDY. MEETING ABSTRACT FROM THE 111TH ANNUAL MEETING OF THE JAPANESE UROLOGICAL ASSOCIATION. 25APR2024, PD ROOM 5, PACIFICO YOKOHAMA NORTH 1F G5+G6. PDA-09-06.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT RETROSPECTIVE REVIEW WAS PERFORMED OF PATIENTS WHO UNDERWENT ARTIFICIAL URINARY SPHINCTER (AUS) PROCEDURES FOLLOWING RADICAL PROSTATECTOMY. THE PURPOSE OF THE STUDY WAS TO ASSESS OUTCOMES OF AUS IMPLANTATIONS. ALL PROCEDURES WERE PERFORMED BETWEEN (B)(6) 2013 AND (B)(6) 2023. A TOTAL OF 22 AUS IMPLANTATIONS WERE PERFORMED IN 21 CASES. FOLLOWING THE PROCEDURES, THERE WERE TWO CASES OF INFECTION, AND ONE PERINEAL HEMATOMA. IN BOTH CASES OF INFECTION, THE AUS DEVICES WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186708 AMS 800 URINARY CONTROL SYSTEM DEVICE INCONTINENCE MECHANICAL/HYDRAULIC EZY BOSTON SCIENTIFIC CORPORATION UNK-P-AUS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H