BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIARC SINGLE-INCISION SLING

    MDR report key: 2651102 · Received July 9, 2012

    Report

    Report Number
    2183959-2012-01173
    Event Type
    Injury
    Date Received
    July 9, 2012
    Report Date
    June 13, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL 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

    PLAINTIFF WAS IMPLANTED WITH A MINIARC TRANSVAGINAL SYNTHETIC MESH SYSTEM. THE IMPLANT DATE WAS NOT REPORTED. IT WAS ALLEGED BY THE PLAINTIFF'S ATTORNEY THAT, AFTER, AND AS A RESULT OF THE IMPLANTATION OF MESH, PLAINTIFF SUFFERED SERIOUS BODILY INJURIES, INCLUDING, BUT NOT LIMITED TO, EXTREME PAIN AND SUFFERING, EROSION OF THEIR INTERNAL BODILY TISSUE, DYSPAREUNIA, PAINFUL SCARRING, AND ADDITIONAL SURGERY. IT WAS FURTHER ALLEGED THAT PLAINTIFF HAS SUFFERED SIGNIFICANT HARM AND BODILY IMPAIRMENT RESULTING PERMANENT PHYSICAL DEFICITS, AND OTHER SEQUELA LIKELY TO CONTINUE MANIFESTING IN THE FUTURE, AND HAS SUFFERED INJURIES FROM MESH EROSION, HARDENING, CHRONIC PAIN, AND WORSENING URINATION. ALSO ALLEGED WAS THAT PLAINTIFF HAS REQUIRED AND WILL CONTINUE TO REQUIRE HEALTHCARE AND SERVICES; HAS SUFFERED AND WILL CONTINUE TO SUFFER GREAT EMBARRASSMENT AND HUMILIATION, MENTAL ANGUISH, DIMINISHED CAPACITY FOR THE ENJOYMENT OF LIFE, A DIMINISHED QUALITY OF LIFE, AND OTHER SUCH DAMAGES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S