BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVANCE MALE SLING SYSTEM

    MDR report key: 2800821 · Received October 17, 2012

    Report

    Report Number
    2183959-2012-02860
    Event Type
    Injury
    Date Received
    October 17, 2012
    Date of Event
    February 1, 2008
    Report Date
    October 11, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADD¿L INFO BECOMES AVAILABLE REGARDING THIS EVENT IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ON (B)(6) 2004 AN INVANCE SLING WAS IMPLANTED TO TREAT PTS URINARY INCONTINENCE. IT WAS REPORTED THAT AFTER THE SLING IMPLANT THE PT EXPERIENCED A GREATER AMOUNT OF INCONTINENCE THAN BEFORE THE SLING WAS IMPLANTED. THE PT RETURNED IN FEBRUARY OF 2008 FOR AN ADD¿L INCONTINENCE DEVICE IMPLANT DUE TO CONTINUED INCONTINENCE. IT WAS REPORTED THE PT HAS HAD GOOD RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVANCE MALE SLING SYSTEM SURGICAL MESH FTL AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R ARTIFICIAL URINARY SPHINCTER