BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS SPHINCTER 800 URINARY PROSTHESIS

    MDR report key: 2546390 · Received April 19, 2012

    Report

    Report Number
    2183959-2012-00443
    Event Type
    Injury
    Date Received
    April 19, 2012
    Date of Event
    December 19, 2011
    Report Date
    December 20, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FAG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFO 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 ORIGINALLY HAD AN ARTIFICIAL URINARY SPHINCTER SYSTEM WITH TANDEM CUFF PLACEMENT. IT WAS REPORTED THE PT EXPERIENCED RECURRING INCONTINENCE AND HAD ONE CUFF REPLACED. ADDITIONAL INFO WAS REQUESTED, BUT NOT PROVIDED.

    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.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R