BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERIGEE

    MDR report key: 2770375 · Received October 1, 2012

    Report

    Report Number
    2183959-2012-02802
    Event Type
    Injury
    Date Received
    October 1, 2012
    Report Date
    March 30, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    RELATED TO MFR REPORT # 2183959-2012-02801. ON OR ABOUT (B)(6) 2008, PLAINTIFF WAS IMPLANTED WITH A PERIGEE GRAFT WITH INTEXEN, WITH THE INTENTION OF TREATING THE PLAINTIFF FOR "STRESS URINARY INCONTINENCE AND PELVIC ORGAN PROLAPSE." IT WAS ALLEGED THAT, "AFTER AND AS A RESULT OF THE IMPLANTATION, PLAINTIFF SUFFERED SERIOUS BODILY INJURIES, INCLUDING, BUT NOT LIMITED TO, EXTREME PAIN, DYSPAREUNIA, URINE LEAKAGE AND OTHER INJURIES." IT WAS ALSO ALLEGED THAT THE PLAINTIFF, "HAS EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, REQUIRED ADDITIONAL SURGERY AND MEDICAL TREATMENT AND SHE HAS SUSTAINED PERMANENT INJURY."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S MINIARC SLING SYSTEM