BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIARC SLING SYSTEM

    MDR report key: 2770346 · Received October 1, 2012

    Report

    Report Number
    2183959-2012-02790
    Event Type
    Injury
    Date Received
    October 1, 2012
    Report Date
    March 28, 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 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 BY THE PLAINTIFF'S ATTORNEY THAT THE "PLAINTIFF HAS A CONDITION THAT REQUIRED SURGICAL INTERVENTION FOR REPAIR." THE PLAINTIFF WAS IMPLANTED WITH THE AMS MINIARC SYNTHETIC MESH SYSTEM ON (B)(6) 2008. IT WAS ALLEGED BY THE PLAINTIFF'S THAT, "WITHIN MONTHS AFTER THE INITIAL IMPLANT PROCEDURE, PLAINTIFF EXPERIENCED COMPLICATIONS," AND "REQUIRED ADD'L MEDICAL CARE AND TREATMENT AND/OR SURGICAL INTERVENTION." IT WAS ALSO ALLEGED THAT, "AS A RESULT OF THE SUBJECT SYNTHETIC MESH SYSTEM, PLAINTIFF SUFFERED DEBILITATING INJURIES FROM THE SYNTHETIC MESH INCLUDING MESH EROSION, HARDENING, CHRONIC PAIN AND WORSENING URINATING LEADING TO THE NEED FOR DANGEROUS AND SERIOUS SURGERY," AND "HAS SUFFERED AND WILL CONTINUE TO SUFFER MENTAL ANGUISH, DIMINISHED CAPACITY FOR THE ENJOYMENT OF LIFE, A DIMINISHED QUALITY OF LIFE, CHRONIC DEBILITATING PAIN, AND OTHER SUCH DAMAGES."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S