BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-QUR MESH

    MDR report key: 3853036 · Received May 22, 2014

    Report

    Report Number
    1219977-2014-00163
    Event Type
    Injury
    Date Received
    May 22, 2014
    Date of Event
    November 1, 2012
    Report Date
    April 22, 2014
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    FTL
    PMA / PMN Number
    K050311
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION INTO THIS EVENT. THIS REPORT IS BASED UPON ALLEGATIONS MADE IN A LAWSUIT IN WHICH ATRIUM MEDICAL IS NAMED DEFENDANT.

    Description of Event or Problem · 1

    THIS EVENT IS DEEMED REPORTABLE BASED ON THE ALLEGATIONS IN A LAWSUIT WHICH, WHILE UNSUBSTANTIATED, SUGGEST THAT A REPORTABLE EVENT MAY HAVE OCCURRED DURING USE OF ATRIUM MEDICALS MESH PRODUCT. PLAINTIFF HAD MESH IMPLANTED TO REPAIR A HERNIA. LATER PLAINTIFF WAS HOSPITALIZED FOR PLACEMENT OF A DRAIN. SURGERY WAS PERFORMED IN (B)(6) 2012 IN WHICH 2 FEET OF PLAINTIFF'S BOWEL WAS REMOVED. SINCE THIS IS A LEGAL MATTER, THE CASE HAS BEEN TURNED OVER TO LEGAL COUNSEL AND FURTHER INFORMATION OBTAINED THROUGH INVESTIGATION OR DISCOVERY MAY FALL UNDER THE ATTORNEY/CLIENT AND /OR WORK PRODUCT PRIVILEGE. HOWEVER, ATRIUM WILL SUPPLEMENT THIS REPORT AS APPROPRIATE IF ADDITIONAL INFORMATION COMES TO ITS ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306820 C-QUR MESH MESH, SURGICAL, POLYMERIC FTL ATRIUM MEDICAL CORPORATION 31528 10572728

    Patients

    Seq Age Sex Outcome Treatment
    1 Other