BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APOGEE SYSTEM

    MDR report key: 3192020 · Received June 20, 2013

    Report

    Report Number
    2183959-2013-00856
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    December 1, 2005
    Report Date
    September 28, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    OTN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF WAS IMPLANTED WITH AN APOGEE ON (B)(6) 2005 TO TREAT STRESS URINARY INCONTINENCE AND UTERINE/VAGINAL VAULT PROLAPSE. IT WAS ALLEGED THE PLAINTIFF SUFFERED AND WILL CONTINUE TO SUFFER SERIOUS BODILY INJURIES, INCLUDING, BUT NOT LIMITED TO, EROSION OF HER INTERNAL BODILY TISSUE, DYSPAREUNIA, INCONTINENCE, DYSURIA, FREQUENCY, RECURRENT/CHRONIC VAGINAL AND BLADDER INFECTIONS, VAGINAL PAIN, URINARY RETENTION, AND OTHER INJURIES. ON OR ABOUT (B)(6) 2005, (B)(6) 2011, AND (B)(6) 2012, THE PLAINTIFF REQUIRED ADDITIONAL REVISION SURGERIES DUE TO EROSION. THE PLAINTIFF HAS AND WILL CONTINUE TO EXPERIENCE SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, AND HAS SUSTAINED PERMANENT INJURY. RELATED TO MFR REPORT # 2183959-2012-00610.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281800 APOGEE SYSTEM SURGICAL MESH, POLYMERIC OTN AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R| S IMPLANTED:| MONARC | IMPLANTED:| MONARC