BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERIGEE

    MDR report key: 2200835 · Received August 8, 2011

    Report

    Report Number
    2183959-2011-00288
    Event Type
    Injury
    Date Received
    August 8, 2011
    Report Date
    July 19, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT RECEIVED AT AMS INDICATED THAT THE PERIGEE MESH WAS IMPLANTED FOR TREATMENT OF STRESS URINARY INCONTINENCE. ACCORDING TO AMS INSTRUCTIONS FOR USE PERIGEE MESH IS INTENDED FOR TREATMENT OF PELVIC ORGAN PROLAPSE ONLY. SHOULD ADD'L INFO BECOME AVAILABLE REGARDING THIS EVENT IT WILL BE RE-EVALUATED AND A F/U REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO AMS ON (B)(6) 2011 THAT "ON OR ABOUT (B)(6), 2007" A PT WAS IMPLANTED WITH A PERIGEE GRAFT WITH INTEPRO FOR TREATMENT OF PELVIC ORGAN PROLAPSE. SINCE THIS SURGERY, IT WAS INDICATED THAT THE PT HAS PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES WHICH WERE NOT SPECIFIED.

    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 Disability