BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLITE MESH

    MDR report key: 3133207 · Received May 24, 2013

    Report

    Report Number
    1219977-2013-00074
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    February 4, 2011
    Report Date
    April 24, 2013
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    FTL
    PMA / PMN Number
    K930669
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE EVALUATION WAS PERFORMED SINCE THE DEVICE WAS NOT RETURNED TO MANUFACTURER. CURRENTLY IN THE PROCESS OF EVALUATING.

    Description of Event or Problem · 1

    THIS EVENT IS DEEMED REPORTABLE BASED ON THE ALLEGATIONS IN THE LAWSUIT WHICH, WHILE UNSUBSTANTIATED, SUGGEST THAT A REPORTABLE EVENT MAY HAVE OCCURRED DURING USE OF ATRIUM MEDICAL'S PROLITE MESH PRODUCT IN (B)(6) 2010, WHEN THE PLAINTIFF ALLEGEDLY HAD A 3 X 6 INCH PIECE OF PROLITE MESH, CUT DOWN TO 3 X 4 INCH, IMPLANTED IN HER. AFTER USING A CALDERA MESH GRAFT TO CREATE A PUBOVAGINAL SLING, THE CYSTOCELE WAS REDUCED USING A PROLENE MESH AND REAPPROXIMATED LATERALLY TO THE PUBOCERVICAL FASCIA. THE POSTERIOR PORTIONS WERE ALSO FIXED TO THE ANTERIOR VAGINAL EPITHELIUM ON THE INSIDE. THIS REDUCED THE CYSTOCELE ADEQUATELY. SUBSEQUENT TO THE IMPLANTATION, ON (B)(6) 2011, THE PATIENT UNDERWENT SURGERY WHERE AN UNSUCCESSFUL ATTEMPT WAS MADE TO REMOVE THE DEVICES. SINCE THIS IS A LEGAL MATTER, THE CASE HAS BEEN TURNED OVER TO LEGAL COUNSEL AND FURTHER INFORMATION OBTAINED THROUGH INVESTIGATION OR DISCOVERY WILL FALL UNDER THE ATTORNEY/CLIENT AND/OR WORK PRODUCT PRIVILEGE. HOWEVER, ATRIUM WILL SUPPLEMENT THIS REPORT IF ADDITIONAL INFORMATION COMES TO ITS ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232173 PROLITE MESH FTL ATRIUM MEDICAL CORP. 1000306-00 10573406

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention CALDERA MESH GRAFT