BEUDAMED
    FDA Adverse Event Death Summary report: N

    C-QUR MESH

    MDR report key: 8321828 · Received February 8, 2019

    Report

    Report Number
    3011175548-2019-00164
    Event Type
    Death
    Date Received
    February 8, 2019
    Report Date
    February 8, 2019
    Manufacturer
    ATRIUM MEDICAL
    Product Code
    FTL
    PMA / PMN Number
    K050311
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE UNABLE TO FULLY INVESTIGATE THIS EVENT AS NO PRODUCT CODE, LOT NUMBER, OR SAMPLE WAS PROVIDED.

    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 MEDICAL¿S MESH PRODUCT. PLAINTIFF ALLEGEDLY EXPERIENCED MESH ADHERENCE, SEVER SHOCK/SEPSIS, MULTI-ORGAN SYSTEM FAILURE, DEATH ON (B)(6) 2017. 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
    114217 C-QUR MESH MESH, SURGICAL, POLYMERIC FTL ATRIUM MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Death