BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE MALE SLING SYSTEM

    MDR report key: 3062876 · Received April 12, 2013

    Report

    Report Number
    2183959-2013-00797
    Event Type
    Injury
    Date Received
    April 12, 2013
    Date of Event
    January 16, 2013
    Report Date
    March 26, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    OTM
    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

    ON (B)(6) 2012 THE PATIENT WAS IMPLANTED WITH AN ADVANCE MALE SLING FOR THE TREATMENT OF URINARY INCONTINENCE. IT WAS REPORTED THAT THE ADVANCE SLING WAS REMOVED ON (B)(6) 2013 DUE TO EROSION AND INFECTION. THE PATIENT WAS IMPLANTED WITH AN ALTERNATIVE CONTINENCE DEVICE ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158151 ADVANCE MALE SLING SYSTEM SURGICAL MESH OTM AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R