BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARC SLING SYSTEM

    MDR report key: 3030236 · Received March 28, 2013

    Report

    Report Number
    2183959-2013-00765
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    September 20, 2011
    Report Date
    March 15, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    OTN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    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 BY THE PATIENT THAT SHE WAS IMPLANTED WITH A MONARC SLING SYSTEM TO TREAT URINARY INCONTINENCE IN 2008. THE PATIENT RELATES SHE EXPERIENCED RECURRENT STRESS INCONTINENCE AND PAIN WITH INTERCOURSE AND DESIRED TO HAVE THE MESH REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129667 MONARC SLING SYSTEM SURGICAL MESH OTN AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R