BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS SPHINCTER 800 URINARY PROSTHESIS

    MDR report key: 2921805 · Received January 15, 2013

    Report

    Report Number
    2183959-2013-00247
    Event Type
    Injury
    Date Received
    January 15, 2013
    Date of Event
    July 18, 2012
    Report Date
    July 31, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    EZY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS EVENT IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE PT HAD AN AMS ARTIFICIAL URINARY SPHINCTER DEVICE IMPLANTED ON (B)(6) 2012. IT WAS REPORTED THAT A SECOND CUFF WAS ADDED ON (B)(6) 2012 DUE TO RECURRENT INCONTINENCE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2012 INDICATES THAT THE RECURRENT INCONTINENCE WAS SECONDARY TO URETHRAL ATROPHY. NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22948 AMS SPHINCTER 800 URINARY PROSTHESIS ARTIFICIAL URINARY SPHINCTER EZY AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R