BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE MALE SLING SYSTEM

    MDR report key: 2770373 · Received October 1, 2012

    Report

    Report Number
    2183959-2012-02775
    Event Type
    Injury
    Date Received
    October 1, 2012
    Date of Event
    February 8, 2012
    Report Date
    September 10, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 THE PATIENT HAD AN ADVANCE SLING IMPLANTED ON (B)(6) 2009. FOLLOWING THE IMPLANT, THE PATIENT HAD INCONTINENCE THAT WAS MORE THAN BASELINE. THE ADVANCE SLING WAS REMOVED AND ANOTHER CONTINENCE DEVICE WAS IMPLANTED ON (B)(6) 2012. THE PATIENT'S OUTCOME WAS REPORTED TO BE "PERFECT" WITH "RARE LEAKAGE."

    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 73 YR Hospitalization| R| S