BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH

    MDR report key: 2770355 · Received October 1, 2012

    Report

    Report Number
    2183959-2012-02788
    Event Type
    Injury
    Date Received
    October 1, 2012
    Report Date
    March 27, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MODEL OF THE MESH SYSTEM THAT WAS IMPLANTED WAS NOT INDICATED. 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 THE PLAINTIFF HAD BOTH PELVIC ORGAN PROLAPSE AND STRESS URINARY INCONTINENCE AND REQUIRED SURGICAL INTERVENTION. ON (B)(6) 2009, THE PLAINTIFF WAS IMPLANTED WITH AMS MESH PRODUCTS. IT WAS ALLEGED BY THE PLAINTIFF'S ATTORNEY THAT, "SHORTLY AFTER IMPLANTATION, SHE BEGAN EXPERIENCING COMPLICATIONS ATTRIBUTABLE TO THE PRODUCTS." IT WAS ALLEGED THAT THE COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO, "CHRONIC PAIN AND DESTRUCTION OF VAGINAL TISSUE WARRANTING THE NEED FOR ADDITIONAL SURGICAL INTERVENTION." IT WAS ALLEGED THAT THE PLAINTIFF HAS UNDERGONE, "EXTENSIVE MEDICAL TREATMENT, INCLUDING BUT NOT LIMITED TO OPERATIONS TO LOCATE AND REMOVE MESH, OPERATIONS TO ATTEMPT TO REPAIR PELVIC ORGANS, TISSUE, AND NERVE DAMAGE, THE USE OF PAIN CONTROL AND OTHER MEDICATIONS, INJECTIONS INTO VARIOUS AREAS OF THE PELVIS, SPINE AND THE VAGINA AND OPERATIONS TO REMOVE PORTIONS OF THE FEMALE GENITALIA," AND "HAS SUFFERED AND WILL CONTINUE TO SUFFER SEVERE AND PERMANENT BODILY INJURIES AND SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S