BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFAST SLING SYSTEM

    MDR report key: 2802395 · Received October 19, 2012

    Report

    Report Number
    2183959-2012-02892
    Event Type
    Injury
    Date Received
    October 19, 2012
    Report Date
    October 2, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF WAS IMPLANTED WITH A INFLUENCE INFAST SYSTEM ON (B)(6) 1999 TO TREAT STRESS URINARY INCONTINENCE AND CYSTOCELE. IT WAS ALLEGED THE PLAINTIFF SUFFERED SERIOUS BODILY INJURIES, INCLUDING PAINFUL SEXUAL INTERCOURSE, DIFFICULTY URINATING, VAGINAL PAIN, BURNING AND INFECTIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S COLOPLAST/MENTOR| TUTOPLAST/SUSPENDED