BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 800 URINARY CONTROL SYSTEM

    MDR report key: 8622500 · Received May 18, 2019

    Report

    Report Number
    2183959-2019-63217
    Event Type
    Injury
    Date Received
    May 18, 2019
    Date of Event
    February 7, 2019
    Report Date
    May 18, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THE ARTIFICIAL URINARY SPHINCTER REMOVED DUE TO UNSPECIFIED REASONS. A NEW ARTIFICIAL URINARY SPHINCTER CONSISTING OF A CUFF, PUMP, AND BALLOON WERE IMPLANTED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415521 AMS 800 URINARY CONTROL SYSTEM DEVICE INCONTINENCE MECHANICAL/HYDRAULIC EZY BOSTON SCIENTIFIC CORPORATION UNK-P-AUS

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R