BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS ADVANCE MALE SLING SYSTEM

    MDR report key: 3781068 · Received April 30, 2014

    Report

    Report Number
    2183959-2014-00142
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 11, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    OTM
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN ADVANCE SLING IMPLANTED ON AN UNKNOWN DATE. THE PATIENT'S INCONTINENCE WORSENED AFTER THE ADVANCE WAS IMPLANTED. ON (B)(6) 2014, THE PATIENT WAS IMPLANTED WITH ANOTHER INCONTINENCE DEVICE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259781 AMS ADVANCE MALE SLING SYSTEM SURGICAL MESH OTM AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R