BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-QUR MESH

    MDR report key: 3129901 · Received May 22, 2013

    Report

    Report Number
    1219977-2013-00068
    Event Type
    Injury
    Date Received
    May 22, 2013
    Date of Event
    February 12, 2012
    Report Date
    February 14, 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 EVAL WAS PERFORMED SINCE THE DEVICE WAS NOT RETURNED TO THE MFR. 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 AN UMBILICAL HERNIA. ON OR ABOUT (B)(6) 2012, THE PLAINTIFF UNDERWENT GASTRIC BYPASS SURGERY AND THE SURGEON FOUND IT NECESSARY TO ADDRESS A BOWEL RESECTION WHICH WAS ALLEGEDLY A COMPLICATION OF ADHESIONS CAUSED BY THE C-QUR MESH. SINCE THIS IS A LEGAL MATTER, THE CASE HAS BEEN TURNED OVER TO LEGAL COUNSEL AND FURTHER INFO OBTAINED THROUGH INVESTIGATION OR DISCOVERY WILL FALL UNDER THE ATTORNEY/CLIENT AND/OR WORK PRODUCT PRIVILEGE. HOWEVER, ATRIUM WILL SUPPLEMENT THIS REPORT IF ADDITIONAL INFO COMES TO ITS ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227194 C-QUR MESH FTL ATRIUM MEDICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention