BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS SPHINCTER 800 URINARY PROSTHESIS

    MDR report key: 2431151 · Received January 25, 2012

    Report

    Report Number
    2183959-2012-00081
    Event Type
    Injury
    Date Received
    January 25, 2012
    Date of Event
    August 10, 2011
    Report Date
    September 27, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FAG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2007 PT WAS IMPLANTED WITH AUS DEVICE. ON (B)(6) 2011 AMS WAS NOTIFIED THAT THE PHYSICIAN "ADDED 2ND CUFF." AMS CLARIFIED THE REASON FOR THE ADDITION OF A CUFF. ON (B)(6) 2011 AMS RECEIVED A RESPONSE "I BELIEVE IT WAS CUFF ATROPHY." THE DEVICE WAS PATENT AND "WORKING BUT NOT CLOSING OFF COMPLETELY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMS SPHINCTER 800 URINARY PROSTHESIS ARTIFICIAL URINARY SPHINCTER FAG AMERICAN MEDICAL SYSTEMS, INC. AUS

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R