BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARC SLING SYSTEM

    MDR report key: 2780500 · Received October 5, 2012

    Report

    Report Number
    2183959-2012-02839
    Event Type
    Injury
    Date Received
    October 5, 2012
    Report Date
    September 7, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 THAT A MONARC WAS IMPLANTED (B)(6) 2009. IT WAS ALLEGED BY THE ATTORNEY THAT THE PLAINTIFF UTILIZED THE PRODUCTS "THUS CAUSING FORESEEABLE INJURIES AND ECONOMIC LOSSES."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability