BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-QUR MESH

    MDR report key: 3146749 · Received June 3, 2013

    Report

    Report Number
    1219977-2013-00071
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    October 10, 2012
    Report Date
    May 21, 2013
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    FTL
    PMA / PMN Number
    K050311
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE EVALUATION WAS PERFORMED SINCE THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED DUE TO THE FACT THAT A DEVICE MODEL NUMBER OR LOT NUMBER WAS NOT PROVIDED.

    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 C-QUR MESH PRODUCT. ON OR ABOUT (B)(6) 2010, PLAINTIFF HAD PIECES OF C-QUR MESH AND PROLOOP MESH, IMPLANTED TO REPAIR A HERNIA. IT IS FURTHER ALLEGED THAT THE MESH WAS DEFECTIVE AND CAUSED SERIOUS INJURY. ON OR ABOUT (B)(6) 2012, THE PLAINTIFF STARTED HAVING PAIN AND WAS HOSPITALIZED FOR SEVERAL DAYS AND WAS TOLD THE MESH IS ROLLED UP INTO A BALL AND HAS FLUID SURROUNDING IT WHICH WAS ALLEGEDLY A COMPLICATION CAUSED BY THE C-QUR MESH. 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
    242565 C-QUR MESH FTL ATRIUM MEDICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other