BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE MALE SLING SYSTEM

    MDR report key: 2890667 · Received December 26, 2012

    Report

    Report Number
    2183959-2012-03429
    Event Type
    Injury
    Date Received
    December 26, 2012
    Date of Event
    August 1, 2010
    Report Date
    December 3, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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

    IT WAS REPORTED THAT AN ADVANCE SLING WAS IMPLANTED ON (B)(6) 2011. THE PATIENT DEVELOPED DE NOVO NOCTURNAL URGE INCONTINENCE ON (B)(6) 2012. THE PATIENT WAS TREATED WITH VESICARE 5 MG PER DAY. THE EVENT STATUS IS REPORTED AS CONTINUING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention