BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH

    MDR report key: 2940549 · Received January 30, 2013

    Report

    Report Number
    2183959-2013-00510
    Event Type
    Injury
    Date Received
    January 30, 2013
    Report Date
    December 17, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN WHICH PELVIC MESH PRODUCT WAS IMPLANTED IN 2001. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS EVENT, IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT AS APPROPRIATE. LAWYER-FILED REPORT-(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF EXPERIENCED EMOTIONAL DISTRESS AND A PROBLEM WITH THE PRODUCT. RELATED TO MFR REPORT # 2183959-2013-00509.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40635 MESH SURGICAL MESH FTL AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability MONARC SLING SYSTEM | MONARC SLING SYSTEM