BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-QUR MESH

    MDR report key: 3049747 · Received April 8, 2013

    Report

    Report Number
    1219977-2013-00031
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 25, 2011
    Report Date
    March 11, 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 A PIECE OF C-QUR MESH, IMPLANTED TO REPAIR A HERNIA. IT IS FURTHER ALLEGED THAT THE MESH WAS DEFECTIVE AND CAUSED SERIOUS INJURY. ON OR ABOUT (B)(6) 2010, THE SURGEON NOTED THERE WAS EXPOSED MESH ALONG WITH ABDOMINAL WOUND ABSCESS ALLEGEDLY CAUSED BY THE C-QUR MESH. THE SURGEON DETERMINED REPAIR SURGERY WAS NECESSARY, HOWEVER, ON (B)(6) 2011, THE MESH WAS EXPLANTED DUE TO WOUND ABSCESS WITH EXPOSED 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
    142502 C-QUR MESH FTL ATRIUM MEDICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other