BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE MALE SLING SYSTEM

    MDR report key: 2963234 · Received February 12, 2013

    Report

    Report Number
    2183959-2013-00675
    Event Type
    Injury
    Date Received
    February 12, 2013
    Date of Event
    December 2, 2010
    Report Date
    January 15, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ADVANCE SLING WAS IMPLANTED ON (B)(6)2010 TO TREAT FOR URINARY INCONTINENCE. ON (B)(6) 2010 A URINALYSIS CONFIRMED A URINARY TRACT INFECTION (UTI). THE EVENT WAS REPORTED AS PROCEDURE RELATED. THE UTI WAS TREATED WITH CIPROFLOXACINE ON (B)(6)2010 AND WAS RESOLVED ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61954 ADVANCE MALE SLING SYSTEM SURGICAL MESH, POLYMERIC FTL AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention