BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVANCE MALE SLING SYSTEM

    MDR report key: 2960239 · Received February 8, 2013

    Report

    Report Number
    2183959-2013-00639
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    January 1, 2008
    Report Date
    January 15, 2013
    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 BECOME AVAILABLE REGARDING THIS EVENT IT WILL BE RE-EVALUATED AND A F/U REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH AN INVANCE SLING ON (B)(6) 2002 TO TREAT FOR INCONTINENCE. IT WAS REPORTED THAT THE INVANCE WAS REMOVED IN 2008 DUE TO INFECTION. THE PT EXPERIENCED RECURRING INCONTINENCE AND WAS TREATED WITH AN ALTERNATE CONTINENCE DEVICE AND COLLAGEN INJECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53352 INVANCE MALE SLING SYSTEM SURGICAL MESH FTL AMERICAN MEDICAL SYSTEMS, INC. 345300

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R