BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE MALE SLING SYSTEM

    MDR report key: 2842108 · Received November 13, 2012

    Report

    Report Number
    2183959-2012-03009
    Event Type
    Injury
    Date Received
    November 13, 2012
    Report Date
    October 25, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, 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

    AN ADVANCE SLING WAS IMPLANTED ABOUT FOUR YEARS AGO. IT WAS REPORTED THAT THE SLING HAS ERODED INTO THE URETHRA AND THAT REVISION SURGERY WAS POSTPONED BECAUSE THE PATIENT IS ON PLAVIX POST/HEART SURGERY DONE TWO YEARS AGO WHERE TWO HEART VALVES WERE REPLACED. DURING THIS HOSPITALIZATION THE PATIENT HAD A FOLEY CATHETER, THOUGHT TO BE A CONTRIBUTING FACTOR TO THE URETHRAL EROSION. THE PATIENT HAS BEEN REFERRED TO ANOTHER UROLOGIST WHO WILL PERFORM THE SLING REVISION SURGERY.

    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 Other| S